The following data is part of a premarket notification filed by Sutter Medizintechnik Gmbh with the FDA for Sutter Bipolar Forceps-calvian.
| Device ID | K150959 |
| 510k Number | K150959 |
| Device Name: | Sutter Bipolar Forceps-Calvian |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SUTTER MEDIZINTECHNIK GMBH TULLASTRASSE 87 Freiburg, DE 79108 |
| Contact | Bert Sutter |
| Correspondent | Ulrike Zeissler SUTTER MEDIZINTECHNIK GMBH TULLASTRASSE 87 Freiburg, DE 79108 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-10 |
| Decision Date | 2015-09-10 |
| Summary: | summary |