SURGEONS CHOICE STAPLE, REMOVE/IMPLANT
FDA 510(k) clearance K802783 · decided 1980-12-16
Clearance details
- K-number
- K802783
- Device name
- SURGEONS CHOICE STAPLE, REMOVE/IMPLANT
- Applicant
- Hospital Products Intl.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-04
- Decision date
- 1980-12-16
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- GBN
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, 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 |
|---|---|---|
| MEDDRAINS (K931607) | Armm, Inc. | 1993-08-06 |
Recalls involving this device
No recalls on record reference this clearance.