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FDA 510(k) Application Details - K001218
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K001218
Device Name
Material, Impression
Applicant
JENERIC/PENTRON, INC.
53 NORTH PLAINS INDUSTRIAL RD.
P.O. BOX 724
WALLINGFORD, CT 06492-0724 US
Other 510(k) Applications for this Company
Contact
ANNMARIE TENERO
Other 510(k) Applications for this Contact
Regulation Number
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/17/2000
Decision Date
07/05/2000
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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