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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 K131416
Device Name NOVOPRESS
Applicant
Milka, LLC
1425 Coachlite Dr.
Greenfield,  IN  46140
Applicant Contact JONATHAN KAHAN
Correspondent
Milka, LLC
1425 Coachlite Dr.
Greenfield,  IN  46140
Correspondent Contact JONATHAN KAHAN
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/16/2013
Decision Date 06/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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