FDA 510(k) Application Details - K961714

Device Classification Name Burnisher, Operative

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510(K) Number K961714
Device Name Burnisher, Operative
Applicant DISTRIFLOR S.A.
10200 SOUTH 45 EAST SANDY
SANDY, UT 84070 US
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Contact GLEN PUTNAM
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Regulation Number 872.4565

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Classification Product Code EKJ
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Date Received 05/02/1996
Decision Date 06/10/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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