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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K080538
Device Name IDEAL LIFE POD (MODEL ILP 0001)
Applicant
IDEAL LIFE INC.
2995 STEVEN MARTIN DR
FAIRFAX,  VA  22031
Applicant Contact Diane Horwitz
Correspondent
IDEAL LIFE INC.
2995 STEVEN MARTIN DR
FAIRFAX,  VA  22031
Correspondent Contact Diane Horwitz
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received02/26/2008
Decision Date 07/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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