The following data is part of a premarket notification filed by Olsen Electro-surgical Instruments, Inc. with the FDA for Olsen #770 Disposable Holster.
Device ID | K820158 |
510k Number | K820158 |
Device Name: | OLSEN #770 DISPOSABLE HOLSTER |
Classification | Instrument, Surgical, Disposable |
Applicant | OLSEN ELECTRO-SURGICAL INSTRUMENTS, INC. CA |
Product Code | KDC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-20 |
Decision Date | 1982-02-05 |