FDA 510(k) Application Details - K990049

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

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510(K) Number K990049
Device Name System,X-Ray,Extraoral Source,Digital
Applicant DIGIDENT LTD.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact MARY MCNAMARA-CULLINAME
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 01/07/1999
Decision Date 03/12/1999
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 N
Expedited Review



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