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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 K151437
Device Name ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
Applicant
Atrium Medical Corporation
5 Wentworth Dr.
Hudson,  NH  03051
Applicant Contact TIMOTHY J. TALCOTT
Correspondent
Atrium Medical Corporation
5 Wentworth Dr.
Hudson,  NH  03051
Correspondent Contact TIMOTHY J. TALCOTT
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/29/2015
Decision Date 08/27/2015
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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