FDA 510(k) Application Details - K963078

Device Classification Name Cement, Dental

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510(K) Number K963078
Device Name Cement, Dental
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 872.3275

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Classification Product Code EMA
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Date Received 08/08/1996
Decision Date 09/10/1996
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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