The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for #500 Series Forceps W/cut/coagulate Switches.
Device ID | K885199 |
510k Number | K885199 |
Device Name: | #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES |
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 |