FDA 510(k) Application Details - K071858

Device Classification Name Instruments, Dental Hand

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510(K) Number K071858
Device Name Instruments, Dental Hand
Applicant FLY CAST TECHNOLOGIES, INC.
P.O. BOX 848
GRAYSLAKE, IL 60030 US
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Contact MICHELE H VOVOLKA
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Regulation Number 872.4565

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Classification Product Code DZN
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Date Received 07/05/2007
Decision Date 08/31/2007
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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