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510(k) K011419

CAVEX COLORCHANGE by Cavex Holland BV — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2001
Date Received
May 9, 2001
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)

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