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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name meter, conductivity, induction, remote type
510(k) Number K100237
Device Name DIALYSATE METER, MODEL D-6
Applicant
MYRON L COMPANY
2450 IMPALA DR.
CARLSBAD,  CA  92010 -7226
Applicant Contact RICHARD JAMES SPAHL
Correspondent
MYRON L COMPANY
2450 IMPALA DR.
CARLSBAD,  CA  92010 -7226
Correspondent Contact RICHARD JAMES SPAHL
Regulation Number876.5820
Classification Product Code
FLB  
Date Received01/26/2010
Decision Date 04/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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