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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K050786
Device Name BARRIER SURGICAL GOWNS
Applicant
Molnlycke Health Care
826 Newton Yardley Rd.
Newton,  PA  18940
Applicant Contact JOHN CLAY
Correspondent
Molnlycke Health Care
826 Newton Yardley Rd.
Newton,  PA  18940
Correspondent Contact JOHN CLAY
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/28/2005
Decision Date 05/09/2005
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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