MAGILL FORCEPS
FDA 510(k) clearance K880319 · decided 1988-03-21
Clearance details
- K-number
- K880319
- Device name
- MAGILL FORCEPS
- Applicant
- Eastmed Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-01-26
- Decision date
- 1988-03-21
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- BWB
- Device class
- 1
- Regulation number
- 868.5780
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Marlton, NJ, 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 |
|---|---|---|
| TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS (K884584) | Eastmed Enterprises, Inc. | 1988-11-14 |
| ROVENSTEIN FORCEPS (K880318) | Eastmed Enterprises, Inc. | 1988-03-21 |
| CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV (K840313) | Imm Enterprises , Ltd. | 1984-02-04 |
| OP-CON SURGICAL INSTRUMENT #9 (K834169) | Imm Enterprises , Ltd. | 1984-01-17 |
| INTRODUCER FOR ENDOTRACHEAL TUBE (K820451) | Imed Corp. | 1982-03-26 |
Recalls involving this device
No recalls on record reference this clearance.