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FDA 510(k) Application Details - K983266
Device Classification Name
Post, Root Canal
More FDA Info for this Device
510(K) Number
K983266
Device Name
Post, Root Canal
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
MURRAY G GAMBERG
Other 510(k) Applications for this Contact
Regulation Number
872.3810
More FDA Info for this Regulation Number
Classification Product Code
ELR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/17/1998
Decision Date
11/09/1998
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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