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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
Other 510(k) Applications for this Contact
Regulation Number
892.1650
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Classification Product Code
MQB
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More FDA Info for this Product Code
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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