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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 K823191
Device Name DISPOSABLE PLASTIC STOPCOCK
Applicant
VERTEX MEDICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
VERTEX MEDICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.1650
Classification Product Code
DXT  
Date Received10/26/1982
Decision Date 12/30/1982
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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