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FDA 510(k) Application Details - K963403
Device Classification Name
Unit, X-Ray, Extraoral With Timer
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510(K) Number
K963403
Device Name
Unit, X-Ray, Extraoral With Timer
Applicant
NEW IMAGE INDUSTRIES, INC.
2283 COSMOS CT.
CARLSBAD, CA 92009 US
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Contact
DEBRA JACKSON
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Regulation Number
872.1800
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Classification Product Code
EHD
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More FDA Info for this Product Code
Date Received
08/29/1996
Decision Date
01/02/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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