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FDA 510(k) Application Details - K991590
Device Classification Name
Assembly, Knee/Shank/Ankle/Foot, External
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
JOHN HENDRICKSON
Other 510(k) Applications for this Contact
Regulation Number
890.3500
More FDA Info for this Regulation Number
Classification Product Code
ISW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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