RESPIRE BLUE SERIES


Device Classification Name

device, anti-snoring

510(k) Number K111207
Device Name RESPIRE BLUE SERIES
Applicant
RESPIRE MEDICAL
22817 ventura blvd #161
woodland hills, 
CA 
91364

Applicant Contact daniela levy
Correspondent
RESPIRE MEDICAL
22817 ventura blvd #161
woodland hills, 
CA 
91364

Correspodent Contact daniela levy
Regulation Number 872.5570
Classification Product Code
LRK  
Date Received 04/29/2011
Decision Date 08/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No