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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 K851402
Device Name LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE
Applicant
MEDI-TECH, INC.
480 PLESANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Applicant Contact ALBERT P SEPRINSKI
Correspondent
MEDI-TECH, INC.
480 PLESANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Correspondent Contact ALBERT P SEPRINSKI
Regulation Number870.1650
Classification Product Code
DXT  
Date Received04/09/1985
Decision Date 06/10/1985
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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