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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 K130943
Device Name AIGIS RX R PM/ AIGIS RX R ICD
Applicant
TYRX , INC.
1 DEER PARK DR.
SUITE G
MONMOUTH JUNCTION,  NJ  08852
Applicant Contact SUSAN OLINGER
Correspondent
TYRX , INC.
1 DEER PARK DR.
SUITE G
MONMOUTH JUNCTION,  NJ  08852
Correspondent Contact SUSAN OLINGER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/04/2013
Decision Date 05/20/2013
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 Yes
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