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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ph Meter For Dialysis Hydrogen Ion Concentration
510(k) Number K870811
Device Name MODEL 102 PH 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
LRI  
Date Received03/03/1987
Decision Date 03/24/1987
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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