OPERATING ROOM TOWELS

Drape, Surgical

BALDUR SYSTEMS CORP.

The following data is part of a premarket notification filed by Baldur Systems Corp. with the FDA for Operating Room Towels.

Pre-market Notification Details

Device IDK981823
510k NumberK981823
Device Name:OPERATING ROOM TOWELS
ClassificationDrape, Surgical
Applicant BALDUR SYSTEMS CORP. 25 HERITAGE DR. Asheville,  NC  28806
ContactSteve Woody
CorrespondentSteve Woody
BALDUR SYSTEMS CORP. 25 HERITAGE DR. Asheville,  NC  28806
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-22
Decision Date1998-08-11

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