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 |