Data / Medical devices / United States / Combe Products, Inc.
Combe Products, Inc.: FDA-registered device maker in Bo Mariana, PR, United States, 2 510(k) clearances
Combe Products, Inc. is registered with the FDA (registration 2650087) in Bo Mariana, PR, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 21, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2650087
- Address
- El Duque Industrial Park Road 971 Street A, Bo Mariana, PR, United States, 00718
- Owner or operator
- COMBE INCORPORATED (2412672)
- Roles
- Manufacturer
- First device listed
- October 26, 2015
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal | NUC | 2 | Manufacturer | 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 21, 2017 | K171855 | External Moisturizing Gel | NUC | Substantially Equivalent | Combe Incorporated | accessdata.fda.gov |
| May 1, 2015 | K150615 | Vaginal Moisturizing Gel | NUC | Substantially Equivalent | Combe Incorporated | accessdata.fda.gov |
Compare with other makers
Updated July 21, 2017. 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.