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510(k) K130631

BUZZY by Mmj Labs, LLC — Product Code PHW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 13, 2014
Date Received: March 8, 2013
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Cold Pack And Vibrating Massager
Device Class: Class I
Regulation Number: 890.5975
Review Panel: PM
Submission Type

Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture).