FDA 510(k) Application Details - K091035

Device Classification Name Device, Jaw Repositioning

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510(K) Number K091035
Device Name Device, Jaw Repositioning
Applicant BRYAN KEROPIAN DDS
186663 VENTURA BLVD.
SUITE 200
TARZANA, CA 91356 US
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Contact BRYAN KEROPIAN
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Regulation Number 872.5570

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Classification Product Code LQZ
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Date Received 04/10/2009
Decision Date 06/24/2009
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

FDA Source Information for K091035


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