The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for Olsen Laparoscopic Instr, Disposable, Single Use.
Device ID | K912611 |
510k Number | K912611 |
Device Name: | OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord, CA 94520 |
Contact | Maria Mursell |
Correspondent | Maria Mursell 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 | 1991-06-12 |
Decision Date | 1992-04-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00887482151976 | K912611 | 000 |
00887482151969 | K912611 | 000 |
00887482151952 | K912611 | 000 |