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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K130553
Device Name ABSOCLEAR
Applicant
Pharmaplast S.A.E.
1016 Tobiano Ln.
Raleigh,  NC  27614
Applicant Contact CYNTHIA PRITCHARD
Correspondent
Pharmaplast S.A.E.
1016 Tobiano Ln.
Raleigh,  NC  27614
Correspondent Contact CYNTHIA PRITCHARD
Classification Product Code
FRO  
Date Received03/04/2013
Decision Date 07/03/2013
Decision Substantially Equivalent (SESE)
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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