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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sleeve, limb, compressible
510(k) Number K121001
Device Name COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)
Original Applicant
NOVITAS MEDICAL, LLC
451 west lambert road
suite 209
brea,  CA  92821
Original Contact marshal fryman
Regulation Number870.5800
Classification Product Code
JOW  
Subsequent Product Code
ILO  
Date Received04/02/2012
Decision Date 04/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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