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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K051625
Device Name BARRIER SURGICAL DRAPES
Applicant
Molnlycke Health Care, Inc.
826 Newtown-Yardley Rd.
Newtown,  PA  18940
Applicant Contact JOHN CLAY
Correspondent
Molnlycke Health Care, Inc.
826 Newtown-Yardley Rd.
Newtown,  PA  18940
Correspondent Contact JOHN CLAY
Regulation Number878.4370
Classification Product Code
KKX  
Date Received06/20/2005
Decision Date 07/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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