The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Non-absorbable Gauze.
| Device ID | K931962 |
| 510k Number | K931962 |
| Device Name: | NON-ABSORBABLE GAUZE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Curtis Raymond |
| Correspondent | Curtis Raymond 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 | 1993-04-21 |
| Decision Date | 1993-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884523000764 | K931962 | 000 |