OROSPHERE PLUS

Alloy, Amalgam

JENERIC/PENTRON, INC.

The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Orosphere Plus.

Pre-market Notification Details

Device IDK890682
510k NumberK890682
Device Name:OROSPHERE PLUS
ClassificationAlloy, Amalgam
Applicant JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford,  CT  06492
ContactPrasad, Ph.d.
CorrespondentPrasad, Ph.d.
JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford,  CT  06492
Product CodeEJJ  
CFR Regulation Number872.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-09
Decision Date1989-05-05

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