KERLIX FLUFFS

Gauze, External (with Drug/biologic/animal Source Material)

STAN-PAK ENT.

The following data is part of a premarket notification filed by Stan-pak Ent. with the FDA for Kerlix Fluffs.

Pre-market Notification Details

Device IDK820053
510k NumberK820053
Device Name:KERLIX FLUFFS
ClassificationGauze, External (with Drug/biologic/animal Source Material)
Applicant STAN-PAK ENT. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGER  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-01-11
Decision Date1982-02-04

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.