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 Disposable Endoscope Sheath.
| Device ID | K934704 |
| 510k Number | K934704 |
| Device Name: | AUTO SUTURE DISPOSABLE ENDOSCOPE SHEATH |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Paul D Smolenski |
| Correspondent | Paul D Smolenski 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 | 1993-09-30 |
| Decision Date | 1994-09-06 |