The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Modified Auto Suture Endoscopic Gia Surg. Stapler*.
| Device ID | K900129 |
| 510k Number | K900129 |
| Device Name: | MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER* |
| Classification | Staple, Implantable |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Curtis Raymond |
| Correspondent | Curtis Raymond 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 | 1990-01-03 |
| Decision Date | 1990-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942567829 | K900129 | 000 |
| 20884523003793 | K900129 | 000 |
| 20884523003731 | K900129 | 000 |
| 20884523003748 | K900129 | 000 |
| 10884523003758 | K900129 | 000 |
| 20884523003762 | K900129 | 000 |
| 20884523003779 | K900129 | 000 |
| 10889942264322 | K900129 | 000 |
| 10889942324897 | K900129 | 000 |
| 20884523003786 | K900129 | 000 |