The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Auto Suture Disposable Gia Surg. Stapler.
| Device ID | K801590 |
| 510k Number | K801590 |
| Device Name: | AUTO SUTURE DISPOSABLE GIA SURG. STAPLER |
| Classification | Apparatus, Suturing, Stomach And Intestinal |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FHM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-11 |
| Decision Date | 1980-08-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521031637 | K801590 | 000 |
| 10884521063402 | K801590 | 000 |
| 20884523007098 | K801590 | 000 |