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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mouthguard, over-the-counter
510(k) Number K100545
Device Name SLEEPRIGHT
Applicant
POWER PRODUCTS, INC.-SPLINTEK
9755 RIDGE DRIVE
LENEXA,  KS  66219
Applicant Contact MELAINE HASEK
Correspondent
POWER PRODUCTS, INC.-SPLINTEK
9755 RIDGE DRIVE
LENEXA,  KS  66219
Correspondent Contact MELAINE HASEK
Classification Product Code
OBR  
Date Received02/26/2010
Decision Date 06/04/2010
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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