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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, biofeedback
510(k) Number K151050
Device Name Pacifier Activated Lullaby (PAL®)
Power Medical Devices, LLC
1615 S.Congress Ave, Ste 13
Delray Beach,  FL  33445
Applicant Contact Patricia Palmer
MEDIcept, INC,
200 Homer Avenue
Ashland,  MA  01721
Correspondent Contact Sharyn Orton
Regulation Number882.5050
Classification Product Code
Date Received04/20/2015
Decision Date 12/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls