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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K993128
Device Name HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
Applicant
Health Hero Network, Inc.
2570 W. El Camino Real
Suite 111
Mountain View,  CA  94040
Applicant Contact JOE SCHWOEBEL
Correspondent
Health Hero Network, Inc.
2570 W. El Camino Real
Suite 111
Mountain View,  CA  94040
Correspondent Contact JOE SCHWOEBEL
Regulation Number862.1345
Classification Product Code
CGA  
Date Received09/20/1999
Decision Date 11/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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