ZQUIET PRO-PLUS


Device Classification Name

device, anti-snoring

510(k) Number K122475
Device Name ZQUIET PRO-PLUS
Applicant
SLEEPING WELL, LLC
5247 shelburne rd ste 204
shelburne, 
VT 
05482

Applicant Contact daniel webster
Correspondent
SLEEPING WELL, LLC
5247 shelburne rd ste 204
shelburne, 
VT 
05482

Correspodent Contact daniel webster
Regulation Number 872.5570
Classification Product Code
LRK  
Date Received 08/14/2012
Decision Date 12/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No