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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 K132699
Device Name AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)
Applicant
Tyrx, Inc.
1 Deer Park Dr. Suite G
Monmouth Junction,  NJ  08852
Applicant Contact REGINA NOVAK
Correspondent
Tyrx, Inc.
1 Deer Park Dr. Suite G
Monmouth Junction,  NJ  08852
Correspondent Contact REGINA NOVAK
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/29/2013
Decision Date 11/26/2013
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
Predetermined Change
Control Plan Authorized		 No
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