FDA 510(k) Application Details - K960879

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K960879
Device Name Agent, Tooth Bonding, Resin
Applicant PARKELL, INC.
155 SCHMITT BLVD.
P.O. BOX 376
FARMINGDALE, NY 11735 US
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Contact NELSON J GENDUSA
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 03/04/1996
Decision Date 03/22/1996
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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