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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, Deployer
510(k) Number K103269
Device Name PATCHASSIST LARGE
Applicant
Polytouch Medical, Ltd.
755 Westminster St.
Unit 120
Providence,  RI  02903
Applicant Contact LEO BASTA
Correspondent
Polytouch Medical, Ltd.
755 Westminster St.
Unit 120
Providence,  RI  02903
Correspondent Contact LEO BASTA
Regulation Number878.3300
Classification Product Code
ORQ  
Date Received11/04/2010
Decision Date 11/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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