BICUT
Electrosurgical, Cutting & Coagulation & Accessories
BERCHTOLD HOLDING GMBH
The following data is part of a premarket notification filed by Berchtold Holding Gmbh with the FDA for Bicut.
Pre-market Notification Details
| 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 |
Trademark Results [BICUT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BICUT 74306410 1882889 Live/Registered |
INTEGRA ME GMBH 1992-08-20 |
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