The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for Teflon Coated Electrodes/electrodes Handles.
Device ID | K913108 |
510k Number | K913108 |
Device Name: | TEFLON COATED ELECTRODES/ELECTRODES HANDLES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord, CA 94520 |
Contact | Eugene W Olsen |
Correspondent | Eugene W Olsen OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord, CA 94520 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-12 |
Decision Date | 1991-12-23 |