FDA 510(k) Application Details - K990846

Device Classification Name Drill, Bone, Powered

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510(K) Number K990846
Device Name Drill, Bone, Powered
Applicant NOBEL BIOCARE UAS INC
22895 EASTPARK DR.
YORBA LINDA, CA 92887 US
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Contact KIM RENDON
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Regulation Number 872.4120

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Classification Product Code DZI
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Date Received 03/15/1999
Decision Date 06/10/1999
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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