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FDA 510(k) Application Details - K963897
Device Classification Name
Chisel, Osteotome, Surgical
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
872.4565
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Classification Product Code
EMM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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