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510(k) K770558

ISODYNE by Hmw Industries — Product Code ECO

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

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  • K843550 — ORTHOMAG MAGNETIC FORCE SYSTEM (December 21, 1984)
  • K843344 — ACTIVE VERTICAL CORRECTOR ACTIVE BITE (December 3, 1984)