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 |