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FDA 510(k) Application Details - K040599
Device Classification Name
Coating, Filling Material, Resin
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510(K) Number
K040599
Device Name
Coating, Filling Material, 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
872.3310
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Classification Product Code
EBD
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More FDA Info for this Product Code
Date Received
03/08/2004
Decision Date
04/09/2004
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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