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510(k) K151050

Pacifier Activated Lullaby (PAL®) by Power Medical Devices, LLC — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2015
Date Received
April 20, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

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