The following data is part of a premarket notification filed by Berchtold Holding Gmbh with the FDA for Bicut.
Device ID | K915608 |
510k Number | K915608 |
Device Name: | BICUT |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532 |
Contact | Wolfram K Hill |
Correspondent | Wolfram K Hill BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-16 |
Decision Date | 1992-07-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BICUT 74306410 1882889 Live/Registered |
INTEGRA ME GMBH 1992-08-20 |