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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, polymeric
510(k) Number K093524
Device Name PIVIT A/B ST AND PIVIT A/B ST-R
Applicant
TYRX ,INC
1 DEER PARK DRIVE
SUITE G
MONMOUTH JUNCTION,  NJ  08852
Applicant Contact MARK CITRON
Correspondent
TYRX ,INC
1 DEER PARK DRIVE
SUITE G
MONMOUTH JUNCTION,  NJ  08852
Correspondent Contact MARK CITRON
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/16/2009
Decision Date 03/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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