Data / Medical devices / United States / Paradise Marketing Services
Paradise Marketing Services: FDA-registered device maker in Vista, CA, United States, 7 510(k) clearances
Paradise Marketing Services is registered with the FDA (registration 2086832) in Vista, CA, United States. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 25, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2086832
- FEI number
- 3002921123
- Address
- 1420 Decision ST., Vista, CA, United States, 92081
- Owner or operator
- PARADISE MARKETING SERVICES (9039717)
- Roles
- Repackager or relabeler
- First device listed
- December 23, 2015
- Registered through
- 2026
- Brand names listed
- Lifestyles Assorted Flavors, Lifestyles SKYN, Lifestyles SKYN Large, Lifestyles Tuxedo, Paradise Super Thin, Trojan Enz
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Condom, Synthetic | MOL | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2016 | K160399 | Skyn Original Polyisoprene Lubricated Male Condom | MOL | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| May 12, 2010 | K092586 | MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU | HIS | Substantially Equivalent | Innolatex (Thailand) Limited | accessdata.fda.gov |
| April 19, 2000 | K000408 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM | HIS | Substantially Equivalent | Suretex Prophylactics , Ltd. | accessdata.fda.gov |
| January 18, 2000 | K994095 | LATEX CONDOM | HIS | Substantially Equivalent | Thai Nippon Rubber Industry Co., Ltd. | accessdata.fda.gov |
| August 19, 1999 | K992081 | VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL | HIS | Substantially Equivalent | Suretex Prophylactics (India) , Ltd. | accessdata.fda.gov |
| June 6, 1990 | K896987 | RUBBER CONDOM (NON-COLORED) | HIS | Substantially Equivalent | Hankook Latex Gongup Co., Ltd. | accessdata.fda.gov |
| April 16, 1990 | K901192 | TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING) | HIS | Substantially Equivalent | Carter Products | accessdata.fda.gov |
Compare with other makers
Updated July 25, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.