RESOLVE SURGICAL O.R. TOWELS

Drape, Surgical

ALLEGIANCE HEALTHCARE CORP.

The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Resolve Surgical O.r. Towels.

Pre-market Notification Details

Device IDK001667
510k NumberK001667
Device Name:RESOLVE SURGICAL O.R. TOWELS
ClassificationDrape, Surgical
Applicant ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park,  IL  60085
ContactSharon Robbins
CorrespondentSharon Robbins
ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park,  IL  60085
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-31
Decision Date2000-06-23

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