FDA 510(k) Application Details - K152292

Device Classification Name Device, Anti-Snoring

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510(K) Number K152292
Device Name Device, Anti-Snoring
Applicant Respire Medical Holding
18 Bridge Street Suite 4J
Brooklyn, NY 11201 US
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Contact David Walton
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 08/13/2015
Decision Date 12/07/2015
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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