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 Purstring Disp. Automatic.
| Device ID | K901107 |
| 510k Number | K901107 |
| Device Name: | MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC |
| Classification | Clamp, Surgical, General & Plastic Surgery |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Stephen Reitzler |
| Correspondent | Stephen Reitzler UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GDJ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-08 |
| Decision Date | 1990-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521051475 | K901107 | 000 |
| 20884521051437 | K901107 | 000 |