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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K880777
Device Name 8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM
Applicant
Medsurg Industries, Inc.
251 Exchange Place
Herndon,  VA  20170 -4822
Applicant Contact TOM BONNER
Correspondent
Medsurg Industries, Inc.
251 Exchange Place
Herndon,  VA  20170 -4822
Correspondent Contact TOM BONNER
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/26/1988
Decision Date 05/24/1988
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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