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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)
Applicant
NOVITAS MEDICAL, LLC
451 west lambert road
suite 209
brea,  CA  92821
Applicant Contact marshal fryman
Correspondent
INTERTEK TESTING SERVICES
2307 east aurora road
unit b7
twinsburg,  OH  44087
Correspondent Contact william j sammons
Regulation Number870.5800
Classification Product Code
JOW  
Subsequent Product Code
ILO  
Date Received04/02/2012
Decision Date 04/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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