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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact MALANIE HASEK
Classification Product Code
MQC  
Subsequent Product Code
OBR  
Date Received05/21/2007
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
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