SPLINTER FORCEPS 4 1/2
FDA 510(k) clearance K821285 · decided 1982-05-28
Clearance details
- K-number
- K821285
- Device name
- SPLINTER FORCEPS 4 1/2
- Applicant
- Conphar, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-04
- Decision date
- 1982-05-28
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- EFL
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- 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 |
|---|---|---|
| DRESSING FORCEPS (K890243) | Kinetic Medical Products | 1989-01-27 |
| BEACH DRESSING PLIER (K821778) | Pacific Dental Corp. | 1982-07-06 |
| THUMB DRESSING FORCEPS 5 (K821282) | Conphar, Inc. | 1982-05-28 |
| ADSON FORCEPS 4 3/4 (K821284) | Conphar, Inc. | 1982-05-28 |
Recalls involving this device
No recalls on record reference this clearance.