CUSTOMED ORTHOPEDIC II

General Surgery Tray

CUSTOMED, INC.

The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Customed Orthopedic Ii.

Pre-market Notification Details

Device IDK902888
510k NumberK902888
Device Name:CUSTOMED ORTHOPEDIC II
ClassificationGeneral Surgery Tray
Applicant CUSTOMED, INC. CALL BOX 158 Carolina Puerto Rico, 
ContactFelix B Santos
CorrespondentFelix B Santos
CUSTOMED, INC. CALL BOX 158 Carolina Puerto Rico, 
Product CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-02
Decision Date1990-09-10

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