The following data is part of a premarket notification filed by Guenter Bissinger Medizintechnik Gmbh with the FDA for Bissinger Monopolar Cables.
Device ID | K150024 |
510k Number | K150024 |
Device Name: | Bissinger Monopolar Cables |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | GUENTER BISSINGER MEDIZINTECHNIK GMBH HANS-THEISEN-STR. 1 Teningen, DE 79331 |
Contact | Matthias Bissinger |
Correspondent | Matthias Bissinger GUENTER BISSINGER MEDIZINTECHNIK GMBH HANS-THEISEN-STR. 1 Teningen, DE 79331 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-07 |
Decision Date | 2015-02-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10381780150718 | K150024 | 000 |