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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solution-Test Standard-Conductivity, Dialysis
510(k) Number K851362
Device Name STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF
Applicant
Rna Medical Corp.
21 Cummings Park
Suite 228
Woburn,  MA  01801
Applicant Contact ADOLPH E D'AMICO
Correspondent
Rna Medical Corp.
21 Cummings Park
Suite 228
Woburn,  MA  01801
Correspondent Contact ADOLPH E D'AMICO
Regulation Number876.5820
Classification Product Code
FKH  
Date Received04/04/1985
Decision Date 06/12/1985
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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