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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Central Multiple Patient
510(k) Number K852310
Device Name NATURALYTE BICARBONATE CONCENTRATE-DRY PACK
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
FKQ  
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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