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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assembly, knee/shank/ankle/foot, external
510(k) Number K991590
Device Name C-LEG (3C100)
Applicant
OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
3000 XENIUM LANE, SUITE N
PLYMOUTH,  MN  55441
Applicant Contact JOHN HENDRICKSON
Correspondent
OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
3000 XENIUM LANE, SUITE N
PLYMOUTH,  MN  55441
Correspondent Contact JOHN HENDRICKSON
Regulation Number890.3500
Classification Product Code
ISW  
Subsequent Product Code
KFX  
Date Received05/07/1999
Decision Date 07/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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