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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K071061
Device Name ABSORBATACK AND APPLICATOR
Applicant
Sorbx, LLC
P.O. Box 3614
Ponte Vedra Beach,  FL  32004
Applicant Contact MARY LEE WILLETS
Correspondent
Sorbx, LLC
P.O. Box 3614
Ponte Vedra Beach,  FL  32004
Correspondent Contact MARY LEE WILLETS
Regulation Number878.4750
Classification Product Code
GDW  
Date Received04/16/2007
Decision Date 05/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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