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(r) Endoscopic Fan Retractor.
| Device ID | K914190 |
| 510k Number | K914190 |
| Device Name: | AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR |
| Classification | Retractor |
| 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 | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-18 |
| Decision Date | 1992-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884523000822 | K914190 | 000 |
| 20884523000846 | K914190 | 000 |
| 20884523000778 | K914190 | 000 |