PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Synovis Life Technologies. Inc.

The following data is part of a premarket notification filed by Synovis Life Technologies. Inc. with the FDA for Peri-guard Repair Patch & Supple Peri-guard Repair Patch.

Pre-market Notification Details

Device IDK142447
510k NumberK142447
Device Name:PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch
ClassificationPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant Synovis Life Technologies. Inc. 2575 University Ave. W. St. Paul,  MN  55129
ContactJodi Jorgenson
CorrespondentJodi Jorgenson
Synovis Life Technologies. Inc. 2575 University Ave. W. St. Paul,  MN  55129
Product CodeDXZ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-02
Decision Date2015-01-07
Summary:summary

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