The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Modification Auto Suture(r) Endoscopic Clamp.
| Device ID | K904578 |
| 510k Number | K904578 |
| Device Name: | MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP |
| Classification | Motor, Surgical Instrument, Pneumatic Powered |
| 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 | GET |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-02 |
| Decision Date | 1990-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884523000747 | K904578 | 000 |
| 20884523000792 | K904578 | 000 |
| 20884523000785 | K904578 | 000 |
| 20884523000709 | K904578 | 000 |