510(k) K802783
- Device
- SURGEONS CHOICE STAPLE, REMOVE/IMPLANT
- Applicant
- HOSPITAL PRODUCTS INTL.
- 510(k) number
- K802783
- Product code
- GBN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-12-16
- Date received
- 1980-11-04
- Regulation
- 878.4200
- Classification name
- Catheter, Pediatric, General & Plastic Surgery
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 2028046
- 3010131137
- 3008816935
- 3031564283
- 2028523
- 3005049530
- 9680718
- 3029906593
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GBN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931607 | MEDDRAINS | Armm, Inc. | 1993-08-06 |
Legacy Summary#
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FDA Review#
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