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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K860867
Device Name DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS
Original Applicant
MEDICAL COMPONENTS, INC.
1499 delp dr.
harleysville,  PA  19438
Original Contact elisabeth walters
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/07/1986
Decision Date 07/02/1986
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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