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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 K945060
Device Name HERNIA MESH INTRODUCTION SYSTEM
Applicant
Gerard Medical, Inc.
90 Worcester Rd.
Charlton,  MA  01507
Applicant Contact RICHARD CAYER
Correspondent
Gerard Medical, Inc.
90 Worcester Rd.
Charlton,  MA  01507
Correspondent Contact RICHARD CAYER
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
GCJ  
Date Received10/14/1994
Decision Date 03/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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