CUSTOMED HIP PACT

General Surgery Tray

CUSTOMED, INC.

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

Pre-market Notification Details

Device IDK903336
510k NumberK903336
Device Name:CUSTOMED HIP PACT
ClassificationGeneral Surgery Tray
Applicant CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo,  PR  00738
ContactFelix B Santos
CorrespondentFelix B Santos
CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo,  PR  00738
Product CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-25
Decision Date1990-08-29

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