CUSTOMED LAP PACK III

Drape, Surgical

CUSTOMED, INC.

The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Customed Lap Pack Iii.

Pre-market Notification Details

Device IDK902030
510k NumberK902030
Device Name:CUSTOMED LAP PACK III
ClassificationDrape, Surgical
Applicant CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo,  PR  00738
ContactFelix B Santos
CorrespondentFelix B Santos
CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo,  PR  00738
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-04
Decision Date1990-07-12

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