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510(k) K843550

ORTHOMAG MAGNETIC FORCE SYSTEM by Medical Magnetics, Inc. — Product Code ECO

K843550 is an FDA 510(k) premarket notification submitted by Medical Magnetics, Inc. for the device "ORTHOMAG MAGNETIC FORCE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 21, 1984. The device falls under product code ECO (Spring, Orthodontic), a Class I device regulated under 21 CFR 872.5410.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1984
Date Received
September 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spring, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

Other clearances for product code ECO

  • K943068 — MAGNEFORCE (August 17, 1994)
  • K933542 — MESIAL LOOP BAR (August 5, 1994)
  • K942492 — ADJUSTABLE BITE CORRECTOR (July 13, 1994)
  • K844234 — ACTIVE VERTICAL CORRECTOR APPLIANCE (January 4, 1985)
  • K843344 — ACTIVE VERTICAL CORRECTOR ACTIVE BITE (December 3, 1984)
  • K770558 — ISODYNE (April 5, 1977)

FDA data resources