The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Manual Surgical Insrument.
| Device ID | K951589 |
| 510k Number | K951589 |
| Device Name: | MANUAL SURGICAL INSRUMENT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Victor Clavelli |
| Correspondent | Victor Clavelli UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-06 |
| Decision Date | 1995-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521066274 | K951589 | 000 |
| 20884523000730 | K951589 | 000 |
| 20884523000723 | K951589 | 000 |
| 20884523000716 | K951589 | 000 |
| 20884523000693 | K951589 | 000 |