Data / Medical devices / United States / CCB Packaging, Inc.
CCB Packaging, Inc.: FDA-registered device maker in Hiawatha, IA, United States, 5 510(k) clearances
CCB Packaging, Inc. is registered with the FDA (registration 3003592318) in Hiawatha, IA, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 9, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003592318
- Address
- 1905 North Center Point RD., Hiawatha, IA, United States, 52233
- Owner or operator
- CCB Packaging, Inc. (9047401)
- Roles
- Repackager or relabeler
- First device listed
- August 18, 2022
- Registered through
- 2026
- Brand names listed
- Eroxon
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Condom With Nonoxynol-9 | LTZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Condom, Synthetic | MOL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction. | QWW | 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 |
|---|---|---|---|---|---|---|
| June 9, 2023 | DEN220078 | Eroxon | QWW | Unknown | Futura Medical Developments Limited | accessdata.fda.gov |
| August 2, 2017 | K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | MOL | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| January 23, 2017 | K163107 | Lifestyles Zero Lubricated Latex Male Condom | HIS | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| July 31, 2000 | K001883 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM | HIS | Substantially Equivalent | Ansell Healthcare, Inc. | accessdata.fda.gov |
| December 6, 1995 | K941258 | LATEX CONDOM | HIS | Substantially Equivalent | Suretex, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 9, 2023. 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.