ORAVAN OSA


Device Classification Name

device, anti-snoring

510(k) Number K121285
Device Name ORAVAN OSA
Applicant
NEW JERSEY SNORING SOLUTIONS
769 northfield avenue
suite 154
west orange, 
NJ 
07052

Applicant Contact deborah stein
Correspondent
NEW JERSEY SNORING SOLUTIONS
769 northfield avenue
suite 154
west orange, 
NJ 
07052

Correspodent Contact deborah stein
Regulation Number 872.5570
Classification Product Code
LRK  
Date Received 04/30/2012
Decision Date 03/08/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No