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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 K850398
Device Name NU-CATH EMERGENCY KIT
Applicant
Intl. Medical Devices , Ltd.
2049 Century Park E.
Suite 1200, Two Century Plz.
Los Angeles,  CA  90067
Applicant Contact JAY H GELLER
Correspondent
Intl. Medical Devices , Ltd.
2049 Century Park E.
Suite 1200, Two Century Plz.
Los Angeles,  CA  90067
Correspondent Contact JAY H GELLER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/01/1985
Decision Date 03/27/1985
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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