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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 K844734
Device Name ALCIDE REN NEW-D
Applicant
Alcide Corp.
125 Main St.
Westport,  CT  06880
Applicant Contact HARRY M KAUFMAN
Correspondent
Alcide Corp.
125 Main St.
Westport,  CT  06880
Correspondent Contact HARRY M KAUFMAN
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received12/04/1984
Decision Date 05/17/1985
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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