FDA 510(k) Application Details - K962031

Device Classification Name File, Pulp Canal, Endodontic

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510(K) Number K962031
Device Name File, Pulp Canal, Endodontic
Applicant TYCOM DENTAL
17802 FITCH AVE.
IRVINE, CA 92714 US
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Contact CAROL L PATTERSON
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Regulation Number 872.4565

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Classification Product Code EKS
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Date Received 05/24/1996
Decision Date 06/04/1996
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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