PRECISE ILA AND ILAN SURGICAL STAPLES

Staple, Implantable

3M COMPANY

The following data is part of a premarket notification filed by 3m Company with the FDA for Precise Ila And Ilan Surgical Staples.

Pre-market Notification Details

Device IDK885222
510k NumberK885222
Device Name:PRECISE ILA AND ILAN SURGICAL STAPLES
ClassificationStaple, Implantable
Applicant 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove,  MN  55016
ContactCharles W Opp
CorrespondentCharles W Opp
3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove,  MN  55016
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-20
Decision Date1989-02-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521063188 K885222 000
20884521063171 K885222 000
20884521063164 K885222 000
10884521064607 K885222 000
10884521064614 K885222 000

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