The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Occlusion Clamp** Device.
| Device ID | K964251 |
| 510k Number | K964251 |
| Device Name: | OCCLUSION CLAMP** DEVICE |
| Classification | Clamp, Vascular |
| 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 | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-24 |
| Decision Date | 1997-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521051161 | K964251 | 000 |
| 20884521050409 | K964251 | 000 |
| 20884521051147 | K964251 | 000 |
| 20884521051130 | K964251 | 000 |
| 20884521050447 | K964251 | 000 |
| 20884521050423 | K964251 | 000 |
| 10884521050419 | K964251 | 000 |
| 20884521050386 | K964251 | 000 |