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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 K003284
Device Name PHLEBOPUMP, MODEL 1000
Applicant
Prevent Products, Inc.
1167 Ottawa Ave.
W St Paul,  MN  55118
Applicant Contact CAROL A GARCIA
Correspondent
Prevent Products, Inc.
1167 Ottawa Ave.
W St Paul,  MN  55118
Correspondent Contact CAROL A GARCIA
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/19/2000
Decision Date 01/17/2001
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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