The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Surgical Instrument Guide.
| Device ID | K950007 |
| 510k Number | K950007 |
| Device Name: | SURGICAL INSTRUMENT GUIDE |
| Classification | Guide, Needle, Surgical |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-03 |
| Decision Date | 1995-03-15 |