FDA 510(k) Application Details - K992609

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

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510(K) Number K992609
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant KAY SEE DENTAL MFG. CO.
124 EAST MISSOURI AVE.
KANSAS CITY, MO 64106-1294 US
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Contact CLARK SMITH
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 08/04/1999
Decision Date 09/22/1999
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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