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 Disp. 30, Etc. & Surg. Stap.
| Device ID | K801589 |
| 510k Number | K801589 |
| Device Name: | AUTO SUTURE DISP. 30, ETC. & SURG. STAP |
| Classification | Apparatus, Suturing, Stomach And Intestinal |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| 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 |
|---|---|---|
| 10884521049024 | K801589 | 000 |
| 10884521049000 | K801589 | 000 |
| 10884521048997 | K801589 | 000 |
| 10884521048980 | K801589 | 000 |
| 20884521045962 | K801589 | 000 |