FDA 510(k) Application Details - K083209

Device Classification Name Device, Anti-Snoring

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510(K) Number K083209
Device Name Device, Anti-Snoring
Applicant SPECIALTY APPLIANCE WORKS, INC.
4905 HAMMOND INDUSTRIAL DRIVE
CUMMING, GA 30041 US
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Contact CAROLYN THOMAS
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 10/31/2008
Decision Date 01/27/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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