FDA 510(k) Application Details - K021126

Device Classification Name Resin, Denture, Relining, Repairing, Rebasing

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510(K) Number K021126
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant STICK TECH LTD.
80 PARKWAY WEST
MOUNT VERNON, NY 10552 US
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Contact WILLIAM TROETEL
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 04/08/2002
Decision Date 05/13/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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