GEM Biover Microvascular Clamps

Clamp, Vascular

Synovis Micro Companies Alliance, Inc.

The following data is part of a premarket notification filed by Synovis Micro Companies Alliance, Inc. with the FDA for Gem Biover Microvascular Clamps.

Pre-market Notification Details

Device IDK221843
510k NumberK221843
Device Name:GEM Biover Microvascular Clamps
ClassificationClamp, Vascular
Applicant Synovis Micro Companies Alliance, Inc. (a Subsidiary Of Baxter International, Inc.) 439 Industrial Lane Birmingham,  AL  35211
ContactJulie Carlston
CorrespondentJulie Carlston
Synovis Micro Companies Alliance, Inc. (a Subsidiary Of Baxter International, Inc.) 439 Industrial Lane Birmingham,  AL  35211
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-24
Decision Date2022-09-14

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