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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 K893254
Device Name DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER
Applicant
Dalphi, Inc.
1140 19th St. NW
Washington,  DC  20036
Applicant Contact VON OEHSEN
Correspondent
Dalphi, Inc.
1140 19th St. NW
Washington,  DC  20036
Correspondent Contact VON OEHSEN
Regulation Number890.1575
Classification Product Code
KHX  
Date Received04/28/1989
Decision Date 01/02/1990
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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