FDA 510(k) Application Details - K011723

Device Classification Name Device, Anti-Snoring

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510(K) Number K011723
Device Name Device, Anti-Snoring
Applicant PI MEDICAL
4050 OLSON MENORIAL HIGHWAY
SUITE 350
MINNEAPOLIS, MN 55422 US
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Contact LINDA S ALEXANDER
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 06/04/2001
Decision Date 12/18/2002
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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