FDA 510(k) Application Details - K974671

Device Classification Name Handpiece, Air-Powered, Dental

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510(K) Number K974671
Device Name Handpiece, Air-Powered, Dental
Applicant ATHENA TECHNOLOGY, INC.
984 NORTH AMELIA AVE.
SAN DIMAS, CA 91773 US
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Contact WILLIAM T ANDERSON
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Regulation Number 872.4200

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Classification Product Code EFB
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Date Received 12/15/1997
Decision Date 03/11/1998
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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