EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE

Powered Laser Surgical Instrument

3M COMPANY

The following data is part of a premarket notification filed by 3m Company with the FDA for Em 1149 Optimize Scotchplate Conduc Adhes Disp Ele.

Pre-market Notification Details

Device IDK900332
510k NumberK900332
Device Name:EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE
ClassificationPowered Laser Surgical Instrument
Applicant 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove,  MN  55016
ContactJulia Wannamaker
CorrespondentJulia Wannamaker
3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove,  MN  55016
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-23
Decision Date1990-02-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50707387563498 K900332 000

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