FDA 510(k) Application Details - K041137

Device Classification Name X-Ray, Tomography, Computed, Dental

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510(K) Number K041137
Device Name X-Ray, Tomography, Computed, Dental
Applicant APERIO SERVICES, LLC
950 S. TAMIAMI TRAIL,
SUITE 102
SARASOTA, FL 34236 US
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Contact K. ROBERT WISNER
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Regulation Number 892.1750

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Classification Product Code OAS
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Date Received 04/30/2004
Decision Date 05/14/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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