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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Platform, Force-Measuring
510(k) Number K821255
Device Name ELECTRODYNOGRAM SYSTEM
Applicant
The Langer Group
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
The Langer Group
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.1575
Classification Product Code
KHX  
Date Received04/30/1982
Decision Date 07/02/1982
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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