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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 K130571
Device Name DEVON CIRONA 6100 DVT
Applicant
DEVON MEDICAL INC.
1100 1ST AVENUE
SUITE 100
KING OF PRUSSIA,  PA  19406
Applicant Contact RUTH WU
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.5800
Classification Product Code
JOW  
Date Received03/04/2013
Decision Date 04/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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