Home / 510(k) Clearances / K871900

510(k) K871900

OVER DRAPE LEG HOLDER by Avec Scientific Design Corp. — Product Code KQZ

K871900 is an FDA 510(k) premarket notification submitted by Avec Scientific Design Corp. for the device "OVER DRAPE LEG HOLDER". The FDA issued a decision of Substantially Equivalent on June 16, 1987. The device falls under product code KQZ (Component, Traction, Non-Invasive), a Class I device regulated under 21 CFR 888.5890. Avec Scientific Design Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1987
Date Received
May 15, 1987
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 Avec Scientific Design Corp.

  • K883295 — CHOP SPINE FRAME (August 23, 1988)
  • K874494 — KAMBIN LAMINECTOMY FRAME (November 23, 1987)
  • K872544 — IRRIGATION PRESSURE MONITOR (September 4, 1987)
  • K871981 — BILATERAL CONTINUOUS PASSIVE MOTION DEVICE (June 17, 1987)
  • K871982 — TOURNIQUET PRESSURE REGULATOR (June 9, 1987)

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)
  • 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