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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, impression
510(k) Number K032116
Device Name TULIP COLORSWITCH
Applicant
CAVEX HOLLAND B.V.
PO BOX 852
HAARLEM,  NL 2003 RW
Applicant Contact RICHARD WOORTMAN
Correspondent
CAVEX HOLLAND B.V.
PO BOX 852
HAARLEM,  NL 2003 RW
Correspondent Contact RICHARD WOORTMAN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received07/09/2003
Decision Date 09/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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