FDA 510(k) Application Details - K993958

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

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510(K) Number K993958
Device Name System,X-Ray,Extraoral Source,Digital
Applicant X-CEL X-RAY CORP.
4220 WALLER DR., P.O. BOX 1857
CRYSTAL LAKE, IL 60039-1857 US
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Contact WILLIAM W MORRIS
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 11/22/1999
Decision Date 02/14/2000
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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