FOGARTY 6MM SOFTJAW CLIP

Clamp, Vascular

AMERICAN EDWARDS LABORATORIES

The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Fogarty 6mm Softjaw Clip.

Pre-market Notification Details

Device IDK832554
510k NumberK832554
Device Name:FOGARTY 6MM SOFTJAW CLIP
ClassificationClamp, Vascular
Applicant AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-01
Decision Date1983-09-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00690103044195 K832554 000
00690103044188 K832554 000

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