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 Premium Plus Ceea Disposable Stapler.
| Device ID | K001895 |
| 510k Number | K001895 |
| Device Name: | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER |
| Classification | Staple, Implantable |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Erika J Miller |
| Correspondent | Erika J Miller UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-21 |
| Decision Date | 2000-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884523006589 | K001895 | 000 |
| 20884523006619 | K001895 | 000 |
| 20884523006602 | K001895 | 000 |
| 20884523006596 | K001895 | 000 |
| 20884523006572 | K001895 | 000 |