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 Ta Dispos-staple Cart.
| Device ID | K830199 |
| 510k Number | K830199 |
| Device Name: | AUTO SUTURE TA DISPOS-STAPLE CART |
| Classification | Staple, Implantable |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-20 |
| Decision Date | 1983-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521047669 | K830199 | 000 |
| 20884521047645 | K830199 | 000 |
| 20884521047614 | K830199 | 000 |
| 20884521047607 | K830199 | 000 |
| 20884521047577 | K830199 | 000 |