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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 K902452
Device Name CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER
Applicant
Berner Assoc., Inc.
2525 Nevada Ave. #302
Golden Valley,  MN  55427
Applicant Contact ERIC C STENDER
Correspondent
Berner Assoc., Inc.
2525 Nevada Ave. #302
Golden Valley,  MN  55427
Correspondent Contact ERIC C STENDER
Regulation Number890.5380
Classification Product Code
BXB  
Date Received06/01/1990
Decision Date 06/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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