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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
Device Name 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
Applicant
BIO COMPRESSION SYSTEMS, INC.
1983 Hazelwood Road
TOMS RIVER,  NJ  08754
Applicant Contact Maureen Garner
Correspondent
BIO COMPRESSION SYSTEMS, INC.
1983 Hazelwood Road
TOMS RIVER,  NJ  08754
Correspondent Contact Maureen Garner
Regulation Number890.5650
Classification Product Code
IRP  
Date Received07/17/2012
Decision Date 04/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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