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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name percussor, powered-electric
510(k) Number K121170
Device Name RESIN 11
Original Applicant
24301 woodsage drive
bonita springs,  FL  34134
Original Contact paul dryden
Regulation Number868.5665
Classification Product Code
Date Received04/17/2012
Decision Date 07/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No