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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K935684
Device Name IV START KIT
Applicant
CUSH MEDICAL PRODUCTS
P.O. BOX 247
881 MOUNTAIN VIEW DRIVE
PINEY FLATS,  TN  37686
Applicant Contact STEVE B JOHNSTON
Correspondent
CUSH MEDICAL PRODUCTS
P.O. BOX 247
881 MOUNTAIN VIEW DRIVE
PINEY FLATS,  TN  37686
Correspondent Contact STEVE B JOHNSTON
Regulation Number880.5200
Classification Product Code
LRS  
Date Received11/29/1993
Decision Date 06/10/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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