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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 K905009
Device Name DIGITCARE I.V. START KIT
Applicant
Digitcare Corp.
300 S. Beverly Dr.
Beverly Hils,  CA  90212
Applicant Contact MICHAEL WOOL
Correspondent
Digitcare Corp.
300 S. Beverly Dr.
Beverly Hils,  CA  90212
Correspondent Contact MICHAEL WOOL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/07/1990
Decision Date 12/18/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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