FDA 510(k) Application Details - K000290

Device Classification Name Toothbrush, Manual

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510(K) Number K000290
Device Name Toothbrush, Manual
Applicant BIOLASE TECHNOLOGY, INC.
981 CALLE AMANECER
SAN CLEMENTE, CA 92673 US
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Contact IOANA M RIZOIU
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Regulation Number 872.6855

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Classification Product Code EFW
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Date Received 01/31/2000
Decision Date 04/14/2000
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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