FDA 510(k) Application Details - K041831

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

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510(K) Number K041831
Device Name System,X-Ray,Extraoral Source,Digital
Applicant PROGENY, INC.
1407 BARCLAY BLVD.
BUFFALO GROVE, IL 60089 US
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Contact E.M. DOLAN
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 07/07/2004
Decision Date 08/09/2004
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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