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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 K873410
Device Name DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE
Applicant
Blood Gas Supply Co.
52 Rockland St.
Melrose,  MA  02176
Applicant Contact WELLS BROWN
Correspondent
Blood Gas Supply Co.
52 Rockland St.
Melrose,  MA  02176
Correspondent Contact WELLS BROWN
Regulation Number870.1650
Classification Product Code
DXT  
Date Received08/25/1987
Decision Date 03/25/1988
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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