FDA 510(k) Application Details - K963897

Device Classification Name Chisel, Osteotome, Surgical

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510(K) Number K963897
Device Name Chisel, Osteotome, Surgical
Applicant STERI-OSS, INC.
22895 EASTPARK DR.
YORBA LINDA, CA 92887 US
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Contact DON KENNARD
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Regulation Number 872.4565

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Classification Product Code EMM
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Date Received 09/27/1996
Decision Date 11/06/1996
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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