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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K841092
Device Name HIGH PRESSURE FLEX. CONNECTING TUBING
Applicant
TRONOMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TRONOMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.1650
Classification Product Code
DXT  
Date Received03/13/1984
Decision Date 07/24/1985
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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