STANFORD STERILE LAP SPONGES

Gauze/sponge, Internal, X-ray Detectable

LUKENS CORP.

The following data is part of a premarket notification filed by Lukens Corp. with the FDA for Stanford Sterile Lap Sponges.

Pre-market Notification Details

Device IDK800102
510k NumberK800102
Device Name:STANFORD STERILE LAP SPONGES
ClassificationGauze/sponge, Internal, X-ray Detectable
Applicant LUKENS CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGDY  
CFR Regulation Number878.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-01-16
Decision Date1980-01-28

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