FDA 510(k) Application Details - K974531

Device Classification Name Device, Anti-Snoring

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510(K) Number K974531
Device Name Device, Anti-Snoring
Applicant SNORE - EZZER
1217 SO. GRANDVIEW BLVD.
WAUKESHA, WI 53188 US
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Contact ROBERT A GALL
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 12/02/1997
Decision Date 02/12/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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