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510(k) K770558

ISODYNE by Hmw Industries — Product Code ECO

K770558 is an FDA 510(k) premarket notification submitted by Hmw Industries for the device "ISODYNE". The FDA issued a decision of Substantially Equivalent on April 5, 1977. 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
April 5, 1977
Date Received
March 22, 1977
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)
  • K843550 — ORTHOMAG MAGNETIC FORCE SYSTEM (December 21, 1984)
  • K843344 — ACTIVE VERTICAL CORRECTOR ACTIVE BITE (December 3, 1984)

FDA data resources