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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K850337
Device Name CARDIAC CATHETERIZATION PACK
Applicant
MARWOOD MEDICAL, INC.
BOX 8712
GREENSBORO,  NC  27410
Applicant Contact DENISE RANCK
Correspondent
MARWOOD MEDICAL, INC.
BOX 8712
GREENSBORO,  NC  27410
Correspondent Contact DENISE RANCK
Regulation Number870.1310
Classification Product Code
DRE  
Date Received01/28/1985
Decision Date 02/25/1985
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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