The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for Modified Olsen #770 Disposable Holster.
Device ID | K884172 |
510k Number | K884172 |
Device Name: | MODIFIED OLSEN #770 DISPOSABLE HOLSTER |
Classification | Apparatus, Electrosurgical |
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 | HAM |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-30 |
Decision Date | 1988-10-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30841785109158 | K884172 | 000 |
30841785109134 | K884172 | 000 |
30841785109127 | K884172 | 000 |
30841785109110 | K884172 | 000 |