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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name densitometer, bone
510(k) Number K001429
Device Name MODIFICATION TO ACCUDEXA BONE DENSITOMETER
Applicant
SCHICK TECHNOLOGIES, INC.
31-00 47TH AVE.
LONG ISLAND,  NY  11101
Applicant Contact DANIEL MICHAELI
Correspondent
SCHICK TECHNOLOGIES, INC.
31-00 47TH AVE.
LONG ISLAND,  NY  11101
Correspondent Contact DANIEL MICHAELI
Regulation Number892.1170
Classification Product Code
KGI  
Date Received05/05/2000
Decision Date 05/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
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