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510(k) K852398

VECTOR BAR SUSPENSION/TRACTION UNIT by Powlan Manufacturing Co. — Product Code ILZ

K852398 is an FDA 510(k) premarket notification submitted by Powlan Manufacturing Co. for the device "VECTOR BAR SUSPENSION/TRACTION UNIT". The FDA issued a decision of Substantially Equivalent on August 12, 1985. The device falls under product code ILZ (Accessories, Traction), a Class I device regulated under 21 CFR 890.5925.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1985
Date Received
June 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Traction
Device Class
Class I
Regulation Number
890.5925
Review Panel
PM
Submission Type

Other clearances for product code ILZ

  • K921711 — FLEXION DISTRATION SUPPORT (July 13, 1992)
  • K895382 — VIBRA-TRAC TRACTION TABLE (October 16, 1989)
  • K884340 — AMX-110, AMX-II AND AMX-III (January 24, 1989)
  • K844490 — TRACTION ACCESSORIES (February 21, 1985)
  • K831135 — SAUNDERS #7080 CERVICAL TRACTION SYS (June 24, 1983)
  • K830245 — HEAD HALTER (March 9, 1983)
  • K823659 — PELVIC TRACTION BELT (December 30, 1982)
  • K823166 — PELVIC TRACTION BELT (November 10, 1982)
  • K820663 — BOGER AUTO-TRACTION DEVICE (May 3, 1982)
  • K791808 — CERVI-TRAC (October 1, 1979)

FDA data resources