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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 K001802
Device Name VENODYNE DVT ADVANTAGE MODEL 610
Applicant
Microtek Medical, Inc.
512 Lehmberg Rd.
Columbus,  MS  39702
Applicant Contact THOMAS BONNER
Correspondent
Microtek Medical, Inc.
512 Lehmberg Rd.
Columbus,  MS  39702
Correspondent Contact THOMAS BONNER
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/14/2000
Decision Date 01/09/2001
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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