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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K914037
Device Name MEDSURG O.R. PROCEDURE TRAY
Applicant
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Applicant Contact THOMAS BONNER
Correspondent
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Correspondent Contact THOMAS BONNER
Regulation Number878.4370
Classification Product Code
LRO  
Date Received09/10/1991
Decision Date 06/22/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
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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