FREEWAY COMFORT BITE GUARD


Device Classification Name

mouthguard, prescription

510(k) Number K110468
Device Name FREEWAY COMFORT BITE GUARD
Applicant
RANDMARK DENTAL PRODUCTS, LLC
9109 copenhaver drive
potomac, 
MD 
20854

Applicant Contact norman f estrin
Correspondent
RANDMARK DENTAL PRODUCTS, LLC
9109 copenhaver drive
potomac, 
MD 
20854

Correspodent Contact norman f estrin
Classification Product Code
MQC  
Subsequent Product Code
OBR  
Date Received 02/17/2011
Decision Date 08/05/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No