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510(k) K920850

GAC THUMB-SUCKING CONTROL APPLIANCE by Gac Intl., Inc. — Product Code DZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1992
Date Received
February 25, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K852179 — CERAMIC ORTHODONIT APPLIANCE (August 20, 1985)

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  • K933374 — NITI COIL SPRINGS (November 19, 1993)
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  • K933378 — REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER (November 12, 1993)
  • K933380 — REVERSE SURVE NITI ARCH WIRE (November 12, 1993)