The following data is part of a premarket notification filed by Olsen Medical with the FDA for Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar Forceps.
Device ID | K130669 |
510k Number | K130669 |
Device Name: | SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | OLSEN MEDICAL 1927 N. ARTHUR DR. Columbia City, IN 46725 |
Contact | Dalene Binkley |
Correspondent | Dalene Binkley OLSEN MEDICAL 1927 N. ARTHUR DR. Columbia City, IN 46725 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-12 |
Decision Date | 2013-12-06 |
Summary: | summary |