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510(k) K884132

TECNOL BUCKS TRACTION W/HEEL PROTECTOR by Technol, Inc. — Product Code KQZ

K884132 is an FDA 510(k) premarket notification submitted by Technol, Inc. for the device "TECNOL BUCKS TRACTION W/HEEL PROTECTOR". The FDA issued a decision of Substantially Equivalent on October 11, 1988. The device falls under product code KQZ (Component, Traction, Non-Invasive), a Class I device regulated under 21 CFR 888.5890. Technol, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1988
Date Received
September 30, 1988
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

Other clearances by Technol, Inc.

  • K861528 — TECNOL PERSONAL SHOE COVER (May 12, 1986)

Other clearances for product code KQZ

  • K882640 — TECNOL SECURE-ALL PELVIC TRACTION BELT (July 27, 1988)
  • K871900 — OVER DRAPE LEG HOLDER (June 16, 1987)
  • K871296 — T.E.D.(TM) TRACTION DEVICE (April 15, 1987)
  • K854270 — MURPHY ADJUSTABLE SPLINT (December 9, 1985)
  • K831002 — TPG 1000 (June 24, 1983)
  • K823660 — UNIVERSAL BUCKS TRACTION (December 30, 1982)
  • K823163 — UNIVERSAL BUCKS TRACTION (November 10, 1982)
  • K821252 — HOFFMAN UNIVERSAL FOOT SUPPORT (June 22, 1982)
  • K802869 — BACKTRAC 90-90 TRACTION (December 11, 1980)
  • K781754 — SPLINT, HOAKE INFLATABLE AIR (November 8, 1978)

FDA data resources