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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K902346
Device Name DISPOSABLE CORONARY CONTROL SYRINGE
Applicant
ADVANCE MEDICAL DESIGNS, INC.
808 PICKENS INDUSTRIAL DR.
MARIETTA,  GA  30062
Applicant Contact D ARKIN
Correspondent
ADVANCE MEDICAL DESIGNS, INC.
808 PICKENS INDUSTRIAL DR.
MARIETTA,  GA  30062
Correspondent Contact D ARKIN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/25/1990
Decision Date 06/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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