ENDO OPTIKS VALUE PACK

General Surgery Tray

ENDO OPTICS, INC.

The following data is part of a premarket notification filed by Endo Optics, Inc. with the FDA for Endo Optiks Value Pack.

Pre-market Notification Details

Device IDK923600
510k NumberK923600
Device Name:ENDO OPTIKS VALUE PACK
ClassificationGeneral Surgery Tray
Applicant ENDO OPTICS, INC. C/O KNOPF ASSOCIATES, INC. 28 MARIGOLD LANE Marlboro,  NJ  07746
ContactMartin S Knopf
CorrespondentMartin S Knopf
ENDO OPTICS, INC. C/O KNOPF ASSOCIATES, INC. 28 MARIGOLD LANE Marlboro,  NJ  07746
Product CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-20
Decision Date1993-03-23

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