The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for 600 & 900 Series Electrodes & 755 & 756 Handle.
Device ID | K885200 |
510k Number | K885200 |
Device Name: | 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord, CA 94520 |
Contact | Eugene Olsen |
Correspondent | Eugene 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 | 1988-12-16 |
Decision Date | 1989-01-13 |