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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K991209
Device Name ORAL SLEEP DISORDER AID
Applicant
Perl-Rad Sleep Disorder Lab
5315 Carmel Valley Rd. A-208
Carmel,  CA  93923 -9558
Applicant Contact ARTHUR PERLIS
Correspondent
Perl-Rad Sleep Disorder Lab
5315 Carmel Valley Rd. A-208
Carmel,  CA  93923 -9558
Correspondent Contact ARTHUR PERLIS
Regulation Number872.5570
Classification Product Code
LRK  
Date Received04/09/1999
Decision Date 09/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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