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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K853134
Device Name NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8
Applicant
Erika, Inc.
One Erika Plz.
Rockleigh,  NJ  07647
Applicant Contact DEL DONNA
Correspondent
Erika, Inc.
One Erika Plz.
Rockleigh,  NJ  07647
Correspondent Contact DEL DONNA
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/26/1985
Decision Date 11/06/1985
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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