OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE

Electrosurgical, Cutting & Coagulation & Accessories

OLSEN ELECTROSURGICAL, INC.

The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for Olsen Laparoscopic Instr, Disposable, Single Use.

Pre-market Notification Details

Device IDK912611
510k NumberK912611
Device Name:OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord,  CA  94520
ContactMaria Mursell
CorrespondentMaria Mursell
OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord,  CA  94520
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-12
Decision Date1992-04-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887482151976 K912611 000
00887482151969 K912611 000
00887482151952 K912611 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.