The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Endoscope Suture & Carrier.
| Device ID | K912973 |
| 510k Number | K912973 |
| Device Name: | ENDOSCOPE SUTURE & CARRIER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-08 |
| Decision Date | 1991-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521132082 | K912973 | 000 |
| 20884521132105 | K912973 | 000 |
| 20884521174976 | K912973 | 000 |
| 20884521132068 | K912973 | 000 |
| 20884521132020 | K912973 | 000 |
| 20884521132037 | K912973 | 000 |
| 20884521132051 | K912973 | 000 |
| 20884521183640 | K912973 | 000 |
| 20884521132013 | K912973 | 000 |
| 20884521132112 | K912973 | 000 |