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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name subsystem, proportioning
510(k) Number K800772
Device Name MOD. DM-357 BICARBONATE RETROFIT KIT
Applicant
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5820
Classification Product Code
FKR  
Date Received04/07/1980
Decision Date 05/14/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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