The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Dexide Bipolar Forceps Ii** Device.
Device ID | K993055 |
510k Number | K993055 |
Device Name: | DEXIDE BIPOLAR FORCEPS II** DEVICE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Christopher A Graham |
Correspondent | Christopher A Graham UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-09-13 |
Decision Date | 1999-10-05 |
Summary: | summary |