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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K952975
Device Name ANKLE CALF EXERCISER PHLEBOPUMP
Applicant
Prevent Products, Inc.
1167 Ottawa Ave.
W St Paul,  MN  55118
Applicant Contact CAROL GARCIA
Correspondent
Prevent Products, Inc.
1167 Ottawa Ave.
W St Paul,  MN  55118
Correspondent Contact CAROL GARCIA
Regulation Number890.5380
Classification Product Code
BXB  
Subsequent Product Code
JOW  
Date Received06/27/1995
Decision Date 09/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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