FDA Registration
Active
🇺🇸 United States
COMBE INCORPORATED
Reg #: 2412672
·
FEI: 2412672
·
Expires 2026
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- COMBE INCORPORATED
- Registration Number
- 2412672
- FEI Number
- 2412672
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1101 Westchester Ave
- City
- White Plains
- State
- NY
- ZIP
- 10604
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163395
Owner / Operator
- Firm Name
- COMBE INCORPORATED
- Operator Number
- 2412672
- Address
- 1101 WESTCHESTER AVE., --
- City
- White Plains
- State
- NY
- Postal Code
- 10604
- Country
- US
- Correspondent
- Richard Grabarz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2023-11-17 |
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2023-11-17 |
| Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer | KXX | Class 1 | Dental | No | 1992-10-20 |
| Lubricant, Vaginal, Patient | MMS | Class 1 | General Hospital | No | 2023-11-17 |
Proprietary Names
SEA BOND DENTURE ADHESIVE
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility