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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Absorbent Tipped, Non-Sterile
510(k) Number K063160
Device Name ALLERGEAZE PATCH TEST CHAMBERS
Applicant
SMART PRACTICE
3400 EAST MCDOWELL RD.
PHOENIX,  AZ  85008
Applicant Contact KIM SULLIVAN
Correspondent
SMART PRACTICE
3400 EAST MCDOWELL RD.
PHOENIX,  AZ  85008
Correspondent Contact KIM SULLIVAN
Regulation Number880.6025
Classification Product Code
KXF  
Date Received10/17/2006
Decision Date 12/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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