510(k) K801590
- Device
- AUTO SUTURE DISPOSABLE GIA SURG. STAPLER
- Applicant
- UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
- 510(k) number
- K801590
- Product code
- FHM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-04
- Date received
- 1980-07-11
- Regulation
- 878.4800
- Classification name
- Apparatus, Suturing, Stomach And Intestinal
- 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#
- 1412854
- 9611503
- 1836161
- 3005440795
- 1650907
- 3007597038
- 3018094310
- 3003807268
- 3006542380
- 3035678069
- 3001644167
- 1219930
- 3007222388
- 3008808049
- 3008388437
- 2647580
- 8030607
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FHM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K801589 | AUTO SUTURE DISP. 30, ETC. & SURG. STAP | United States Surgical, A Division of Tyco Healthc | 1980-08-04 |
Legacy Summary#
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FDA Review#
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