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 IDK792471
510k NumberK792471
Device Name:STANFORD STERILE LAP SPONGES
ClassificationGauze/sponge, Internal, X-ray Detectable
Applicant LUKENS CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGDY  
CFR Regulation Number878.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-12-03
Decision Date1979-12-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.