WOUND DRESSING/ABD PAD, MODEL #10810

Dressing, Wound, Drug

HOSPITAL SPECIALTY CO.

The following data is part of a premarket notification filed by Hospital Specialty Co. with the FDA for Wound Dressing/abd Pad, Model #10810.

Pre-market Notification Details

Device IDK990861
510k NumberK990861
Device Name:WOUND DRESSING/ABD PAD, MODEL #10810
ClassificationDressing, Wound, Drug
Applicant HOSPITAL SPECIALTY CO. 7501 CARNEGIE AVE. Cleveland,  OH  44103 -4896
ContactJohn Quigley
CorrespondentJohn Quigley
HOSPITAL SPECIALTY CO. 7501 CARNEGIE AVE. Cleveland,  OH  44103 -4896
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-16
Decision Date1999-04-12
Summary:summary

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