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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 K073013
Device Name CTU676 DEVICE
Applicant
Compression Technologies Unlimited, Inc.
12080 Dawnhaven Ave.
Lansing,  MI  48917
Applicant Contact DOUGLASS HALE
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 Received10/25/2007
Decision Date 11/21/2007
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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