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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 K944355
Device Name NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES
Applicant
Nissho Corp.
7205 Corporate Center Dr.
# 305
Miami,  FL  33126
Applicant Contact LOUIS CANDELARIO
Correspondent
Nissho Corp.
7205 Corporate Center Dr.
# 305
Miami,  FL  33126
Correspondent Contact LOUIS CANDELARIO
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received09/07/1994
Decision Date 12/07/1994
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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