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510(k) K820663

BOGER AUTO-TRACTION DEVICE by D.C. Medical Device, Inc. — Product Code ILZ

K820663 is an FDA 510(k) premarket notification submitted by D.C. Medical Device, Inc. for the device "BOGER AUTO-TRACTION DEVICE". The FDA issued a decision of Substantially Equivalent on May 3, 1982. 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
May 3, 1982
Date Received
March 10, 1982
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)
  • K852398 — VECTOR BAR SUSPENSION/TRACTION UNIT (August 12, 1985)
  • 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)
  • K791808 — CERVI-TRAC (October 1, 1979)

FDA data resources