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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K955053
Device Name NIPRO SCALP VEIN SET (DISPOSABL PSV SET)
Applicant
Nissho Corp.
7205 NW 19th St.
Suite 305
Miami,  FL  33126
Correspondent
Nissho Corp.
7205 NW 19th St.
Suite 305
Miami,  FL  33126
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/06/1995
Decision Date 01/04/1996
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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