AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD

Electrosurgical, Cutting & Coagulation & Accessories

AMERICAN BIOSURGICAL, INC.

The following data is part of a premarket notification filed by American Biosurgical, Inc. with the FDA for American Biosurgical Electrosurgical Bipolar Cable/cord.

Pre-market Notification Details

Device IDK972901
510k NumberK972901
Device Name:AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant AMERICAN BIOSURGICAL, INC. 6665-B CORNERS INDUSTRIAL CT. Norcross,  GA  30092
ContactMichael Socoloff
CorrespondentMichael Socoloff
AMERICAN BIOSURGICAL, INC. 6665-B CORNERS INDUSTRIAL CT. Norcross,  GA  30092
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-06
Decision Date1997-09-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00190776123314 K972901 000
00849593019729 K972901 000
00849593019897 K972901 000
00849593019910 K972901 000
00852028007109 K972901 000
00852028007116 K972901 000
00852028007147 K972901 000
00852028007154 K972901 000
00817914024790 K972901 000
00849593019705 K972901 000

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