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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 K925210
Device Name 90DX MULTITEST METER, MODIFICATION
Applicant
MESA MEDICAL, INC.
3904 YOUNGFIELD ST.
WHEAT RIDGE,  CO  80033
Applicant Contact JEFF ZEPP
Correspondent
MESA MEDICAL, INC.
3904 YOUNGFIELD ST.
WHEAT RIDGE,  CO  80033
Correspondent Contact JEFF ZEPP
Regulation Number876.5820
Classification Product Code
FLB  
Date Received10/07/1992
Decision Date 01/25/1994
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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