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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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More FDA Info for this Product Code
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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