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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing Kit
510(k) Number K931932
Device Name DRESSING CHANGE TRAY-MODIFIED
Applicant
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Applicant Contact THOMAS B BONNER
Correspondent
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Correspondent Contact THOMAS B BONNER
Regulation Number880.5075
Classification Product Code
MCY  
Date Received04/19/1993
Decision Date 08/27/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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