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510(k) K051207

CAVEX ORTHOTRACE by Cavex Holland BV — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2005
Date Received
May 11, 2005
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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  • K032116 — TULIP COLORSWITCH (September 30, 2003)
  • K023466 — TULIP ALGINATE IMPRESSION MATERIAL (December 13, 2002)

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