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510(k) K854270

MURPHY ADJUSTABLE SPLINT by Comfortex, Inc. — Product Code KQZ

K854270 is an FDA 510(k) premarket notification submitted by Comfortex, Inc. for the device "MURPHY ADJUSTABLE SPLINT". The FDA issued a decision of Substantially Equivalent on December 9, 1985. The device falls under product code KQZ (Component, Traction, Non-Invasive), a Class I device regulated under 21 CFR 888.5890. Comfortex, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1985
Date Received
October 23, 1985
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 Comfortex, Inc.

  • K860037 — SUSPENDER ORTHOPEDIC SUSPENSION DEVICE (January 21, 1986)
  • K855179 — TRANSFER-TRAX (TM) SPLINT TRACTION (January 21, 1986)
  • K855181 — COMFORTEX WHEELCHAIR CUSHION (January 13, 1986)

Other clearances for product code KQZ

  • K884132 — TECNOL BUCKS TRACTION W/HEEL PROTECTOR (October 11, 1988)
  • 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)
  • 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