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FDA 510(k) Application Details - K053558
Device Classification Name
System,X-Ray,Extraoral Source,Digital
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510(K) Number
K053558
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
SCHICK TECHNOLOGIES, INC.
30-00 47TH AVE., FIFTH FLOOR
LONG ISLAND CITY, NY 11101 US
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Contact
DANIEL MICHAELI
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Regulation Number
872.1800
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Classification Product Code
MUH
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More FDA Info for this Product Code
Date Received
12/21/2005
Decision Date
02/17/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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