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510(k) K821252

HOFFMAN UNIVERSAL FOOT SUPPORT by Howmedica Corp. — Product Code KQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1982
Date Received
April 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Non-Invasive
Device Class
Class I
Regulation Number
888.5890
Review Panel
OR
Submission Type

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  • K831002 — TPG 1000 (June 24, 1983)
  • K823660 — UNIVERSAL BUCKS TRACTION (December 30, 1982)
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  • K802869 — BACKTRAC 90-90 TRACTION (December 11, 1980)
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