FDA 510(k) Application Details - K031291

Device Classification Name System,X-Ray,Extraoral Source,Digital

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510(K) Number K031291
Device Name System,X-Ray,Extraoral Source,Digital
Applicant SCHICK TECHNOLOGIES, INC.
30-00 47TH AVE.
LONG ISLAND CITY, NY 11101 US
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Contact DANIEL J SHERRATT
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 04/23/2003
Decision Date 05/05/2003
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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