LORREX COVER SPONGES STERILE2'S AND NON-STERILE

Gauze/sponge, Internal

LORREX HEALTH PRODUCTS

The following data is part of a premarket notification filed by Lorrex Health Products with the FDA for Lorrex Cover Sponges Sterile2's And Non-sterile.

Pre-market Notification Details

Device IDK942070
510k NumberK942070
Device Name:LORREX COVER SPONGES STERILE2'S AND NON-STERILE
ClassificationGauze/sponge, Internal
Applicant LORREX HEALTH PRODUCTS 301 PENHORN AVE. Secaucus,  NJ  07094
ContactEric Morales
CorrespondentEric Morales
LORREX HEALTH PRODUCTS 301 PENHORN AVE. Secaucus,  NJ  07094
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-29
Decision Date1994-05-19

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