FDA 510(k) Application Details - K024186

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

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510(K) Number K024186
Device Name System,X-Ray,Extraoral Source,Digital
Applicant SOMETECH CORPORATION
6669 PEACHTREE INDUSTRIAL BLVD
SUITE J
NORCROSS, GA 30092 US
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Contact KI CHEOL HAN
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 12/19/2002
Decision Date 04/01/2004
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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