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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name massager, powered inflatable tube
510(k) Number K122112
Model 2004-OC, 2008-OC
Device Name 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
Original Applicant
BIO COMPRESSION SYSTEMS, INC.
1983 hazelwood road
toms river,  NJ  08754
Original Contact maureen garner
Regulation Number890.5650
Classification Product Code
IRP  
Date Received07/17/2012
Decision Date 04/09/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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