SLEEP RIGHT – SELECT, LOW PROFILE AND ADVANCE

Device Classification Name

mouthguard, prescription

510(k) Number K071404
Device Name SLEEP RIGHT – SELECT, LOW PROFILE AND ADVANCE
Applicant
POWER PRODUCTS, INC.-SPLINTEK
9755 ridge drive
lenexa, 
KS 
66219

Applicant Contact malanie hasek
Correspondent
POWER PRODUCTS, INC.-SPLINTEK
9755 ridge drive
lenexa, 
KS 
66219

Correspodent Contact malanie hasek
Classification Product Code
MQC  
Subsequent Product Code
OBR  
Date Received 05/21/2007
Decision Date 08/17/2007
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No