FDA 510(k) Application Details - K190058

Device Classification Name Device, Anti-Snoring

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510(K) Number K190058
Device Name Device, Anti-Snoring
Applicant Sleep Science Partners, Inc.
900 Larkspur Landing Circle Suite 207
Larkspur, CA 94939 US
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Contact Noel P. Lindsay
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 01/11/2019
Decision Date 04/11/2019
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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