The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Micro-france Electrosurgical Instruments, Various.
Device ID | K993655 |
510k Number | K993655 |
Device Name: | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
Contact | Martin D Sargent |
Correspondent | Martin D Sargent XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-29 |
Decision Date | 1999-12-21 |
Summary: | summary |