The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Rib Resector.
Device ID | K951492 |
510k Number | K951492 |
Device Name: | RIB RESECTOR |
Classification | Instrument, Surgical, Non-powered |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Jane G Johnson |
Correspondent | Jane G Johnson UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | HAO |
CFR Regulation Number | 882.4535 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-31 |
Decision Date | 1995-05-18 |