ACRYLIC HERBST APPLIANCE


Device Classification Name

device, anti-snoring

510(k) Number K111009
Device Name ACRYLIC HERBST APPLIANCE
Applicant
EMBASSY DENTAL LABORATORY
8202 sherman road
chesterland, 
OH 
44026

Applicant Contact karen e warden, phd
Correspondent
EMBASSY DENTAL LABORATORY
8202 sherman road
chesterland, 
OH 
44026

Correspodent Contact karen e warden, phd
Regulation Number 872.5570
Classification Product Code
LRK  
Date Received 04/11/2011
Decision Date 07/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No