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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
Applicant
MEDICAL COMPONENTS, INC.
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Applicant Contact ELISABETH WALTERS
Correspondent
MEDICAL COMPONENTS, INC.
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Correspondent Contact ELISABETH WALTERS
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/07/1986
Decision Date 07/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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