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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 K101523
Device Name CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE
Applicant
Devon Medical, Inc.
1100 1st Ave.
Suite 100
King Of Prussia,  PA  19406
Applicant Contact RUTH WU
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/02/2010
Decision Date 06/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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