HYDRASORB STERILE DRESSING

Dressing, Wound And Burn, Occlusive

CALGON VESTAL DIV.

The following data is part of a premarket notification filed by Calgon Vestal Div. with the FDA for Hydrasorb Sterile Dressing.

Pre-market Notification Details

Device IDK931599
510k NumberK931599
Device Name:HYDRASORB STERILE DRESSING
ClassificationDressing, Wound And Burn, Occlusive
Applicant CALGON VESTAL DIV. 5035 MANCHESTER AVE. St. Louis,  MO  63110
ContactAnne L Schmitt
CorrespondentAnne L Schmitt
CALGON VESTAL DIV. 5035 MANCHESTER AVE. St. Louis,  MO  63110
Product CodeMGP  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-01
Decision Date1993-07-08

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