FDA 510(k) Application Details - K991590

Device Classification Name Assembly, Knee/Shank/Ankle/Foot, External

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510(K) Number K991590
Device Name Assembly, Knee/Shank/Ankle/Foot, External
Applicant OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
3000 XENIUM LANE, SUITE N
PLYMOUTH, MN 55441 US
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Contact JOHN HENDRICKSON
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Regulation Number 890.3500

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Classification Product Code ISW
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Date Received 05/07/1999
Decision Date 07/08/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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