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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K852309
Device Name ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1
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 Number876.5820
Classification Product Code
FJK  
Date Received05/29/1985
Decision Date 07/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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