FDA 510(k) Application Details - K992176

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

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510(K) Number K992176
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant ST. GEORGE TECHNOLOGY, INC.
P.O. BOX 1586
YORK, PA 17405 US
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Contact VERNON WATKINS
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 06/28/1999
Decision Date 02/10/2000
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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