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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 K002093
Device Name ATRIUM LITE MESH
Applicant
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON,  NH  03051
Applicant Contact JOSEPH P DE PAOLO
Correspondent
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON,  NH  03051
Correspondent Contact JOSEPH P DE PAOLO
Regulation Number878.3300
Classification Product Code
FTL  
Date Received07/11/2000
Decision Date 07/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
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