FDA 510(k) Application Details - K991209

Device Classification Name Device, Anti-Snoring

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510(K) Number K991209
Device Name Device, Anti-Snoring
Applicant PERL-RAD SLEEP DISORDER LAB
5315 CARMEL VALLEY RD. A-208
CARMEL, CA 93923-9558 US
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Contact ARTHUR PERLIS
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 04/09/1999
Decision Date 09/22/1999
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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