FDA 510(k) Application Details - K982661

Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)

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510(K) Number K982661
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant SCHICK TECHNOLOGIES, INC.
3100 47TH AVE.
LONG ISLAND, NY 11101 US
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Contact ENRICO RENZI
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 07/30/1998
Decision Date 12/11/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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