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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K864461
Device Name MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY
Applicant
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Applicant Contact DONNA COLLIER
Correspondent
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Correspondent Contact DONNA COLLIER
Regulation Number870.4500
Classification Product Code
DWS  
Date Received11/12/1986
Decision Date 11/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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