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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 K882032
Device Name MODEL 90DX MULTITEST METER
Applicant
MESA MEDICAL, INC.
3904 YOUNGFIELD ST.
WHEAT RIDGE,  CO  80033
Applicant Contact LUKE R SCHMIEDER
Correspondent
MESA MEDICAL, INC.
3904 YOUNGFIELD ST.
WHEAT RIDGE,  CO  80033
Correspondent Contact LUKE R SCHMIEDER
Regulation Number876.5820
Classification Product Code
FLB  
Date Received05/16/1988
Decision Date 08/11/1988
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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