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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 K925822
Device Name CUSTOM SYRIGENE KITS
Applicant
SYRIGENE MEDICAL TECHNOLOGIES, INC.
P.O. BOX 2010
PALM HARBOR,  FL  34682
Applicant Contact PATRICK J LAMB
Correspondent
SYRIGENE MEDICAL TECHNOLOGIES, INC.
P.O. BOX 2010
PALM HARBOR,  FL  34682
Correspondent Contact PATRICK J LAMB
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/17/1992
Decision Date 04/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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