FDA 510(k) Application Details - K021437

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

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510(K) Number K021437
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant IMTEC CORP.
2401 NORTH COMMERCE
ARDMORE, OK 73401 US
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Contact BRAD VANCE
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 05/06/2002
Decision Date 07/19/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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