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510(k) K071192

BLUGOO HD by Lancer Orthodontics, Inc. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2007
Date Received
April 30, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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  • K904092 — LANCER ORIGINAL, SIERRA, GENERAL PURPOSE (November 9, 1990)
  • K904093 — BUCCAL TUBE, BUCCAL ATTACHMENT (November 7, 1990)
  • K904091 — TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO (November 5, 1990)
  • K904089 — PERMA MESH (November 2, 1990)
  • K904094 — C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE (November 2, 1990)
  • K902075 — INTRIGUE CERAMIC BRACKET (August 6, 1990)

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