FDA 510(k) Application Details - K981923

Device Classification Name Device, Anti-Snoring

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510(K) Number K981923
Device Name Device, Anti-Snoring
Applicant THE SNORE PEACE GROUP
24791 VIA SAN FELIPE
MISSION VIEJO, CA 92692 US
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Contact DAVID V SHEEHAN
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 06/01/1998
Decision Date 08/24/1998
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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