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510(k) K791331

THE TUCKER-SACH FOOT AND TUCKER-SYME FT by Kiswood Manufacturing, Inc. — Product Code ISH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1979
Date Received
July 18, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, External, Limb, Ankle/Foot
Device Class
Class I
Regulation Number
890.3420
Review Panel
PM
Submission Type

Other clearances for product code ISH

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  • K823396 — FREE FLEX HEEL HEIGHT ADJUSTOR (November 29, 1982)
  • K820505 — ANKLE/FOOT EXTERNAL (March 8, 1982)