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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 K991637
Device Name BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
Applicant
Davol Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  RI  02920
Applicant Contact RINI GEORGEKUTTY
Correspondent
Davol Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  RI  02920
Correspondent Contact RINI GEORGEKUTTY
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/12/1999
Decision Date 06/22/1999
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
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