COMFEEL PROTECTIVE RINGS
FDA 510(k) clearance K832908 · decided 1983-12-12
Clearance details
- K-number
- K832908
- Device name
- COMFEEL PROTECTIVE RINGS
- Applicant
- Coloplast A/S
- Decision
- Substantially Equivalent
- Date received
- 1983-08-29
- Decision date
- 1983-12-12
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- EYF
- Device class
- 1
- Regulation number
- 878.4014
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IRRIVAGE (K922785) | Autovage | 1992-10-16 |
| HARDING STERNAL SHIELD (K911407) | Harding Medical Devices | 1991-07-05 |
| ANTI-FOG DISPOSABLE IV INDUCTION COVER (K910104) | Central Plastic, Inc. | 1991-04-12 |
| SI-PRO (K904389) | David F. Trungale | 1990-12-17 |
Recalls involving this device
No recalls on record reference this clearance.