Home / 510(k) Clearances / K820505

510(k) K820505

ANKLE/FOOT EXTERNAL by Mauch Laboratories, Inc. — Product Code ISH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1982
Date Received
February 25, 1982
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

  • K051256 — SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC (July 21, 2005)
  • K823396 — FREE FLEX HEEL HEIGHT ADJUSTOR (November 29, 1982)
  • K791331 — THE TUCKER-SACH FOOT AND TUCKER-SYME FT (August 3, 1979)