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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 K863639
Device Name ARTICULAR MOTION DEVICE (AMD4000)
Applicant
Med Surg Designs, Inc.
124 Parker Ct.
Chardon,  OH  44024
Applicant Contact THOMAS J LANG
Correspondent
Med Surg Designs, Inc.
124 Parker Ct.
Chardon,  OH  44024
Correspondent Contact THOMAS J LANG
Regulation Number890.5380
Classification Product Code
BXB  
Date Received09/17/1986
Decision Date 09/29/1986
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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