FDA 510(k) Application Details - K963746

Device Classification Name Floss, Dental

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510(K) Number K963746
Device Name Floss, Dental
Applicant WHITEHILL ORAL TECHNOLOGIES, INC.
950 HIGHWAY 36
HAZLET, NJ 07730 US
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Contact PETER P WALTERS
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Regulation Number 872.6390

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Classification Product Code JES
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Date Received 09/17/1996
Decision Date 12/12/1996
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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