The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Implantable Staple.
Device ID | K950562 |
510k Number | K950562 |
Device Name: | IMPLANTABLE STAPLE |
Classification | Laparoscope, General & Plastic Surgery |
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 | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-08 |
Decision Date | 1995-05-09 |