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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Pressure Measurement, Intermittent
510(k) Number K915278
Device Name CDG GAIT ANALYSES SYSTEM
Applicant
Wrm Computers
P.O. Box 384
7940 Aj Meppel
Holland,  HN
Applicant Contact WILFORD MAURITS
Correspondent
Wrm Computers
P.O. Box 384
7940 Aj Meppel
Holland,  HN
Correspondent Contact WILFORD MAURITS
Regulation Number890.1600
Classification Product Code
JFC  
Date Received11/25/1991
Decision Date 04/07/1992
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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