The following data is part of a premarket notification filed by Berchtold Holding Gmbh with the FDA for Bipolap Hook Electrode.
| Device ID | K950932 |
| 510k Number | K950932 |
| Device Name: | BIPOLAP HOOK ELECTRODE |
| 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 | 1995-03-01 |
| Decision Date | 1995-03-15 |