FDA 510(k) Application Details - K974727

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

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510(K) Number K974727
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant J.B.C AND CO.
23691 VIA DEL RIO
YORBA LINDA, CA 92887 US
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Contact PRISCILLA L MIER
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 12/18/1997
Decision Date 02/24/1998
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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