ORAL SLEEP DISORDER AID


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

Correspodent Contact arthur perlis
Regulation Number 872.5570
Classification Product Code
LRK  
Date Received 04/09/1999
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