FDA 510(k) Application Details - K103586

Device Classification Name Material, Impression

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510(K) Number K103586
Device Name Material, Impression
Applicant IOS TECHNNOLOGIES, INC.
3978 SORRENTO VALLEY BLVD.
SUITE 200
SAN DIEGO, CA 92121 US
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Contact DUANE DURBIN
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Regulation Number 872.3660

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Classification Product Code ELW
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Date Received 12/07/2010
Decision Date 03/30/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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