REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP


Device Classification Name

device, anti-snoring

510(k) Number K103704
Device Name REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP
Applicant
ZEPHYR SLEEP TECHNOLOGIES INC
2513 17 st se
calgary; alberta, 

CA

t2l 2k7

Applicant Contact sabina bruchlmann
Correspondent
ZEPHYR SLEEP TECHNOLOGIES INC
2513 17 st se
calgary; alberta, 

CA

t2l 2k7

Correspodent Contact sabina bruchlmann
Regulation Number 872.5570
Classification Product Code
LRK  
Date Received 12/20/2010
Decision Date 03/23/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No