INTESTINAL SPONGES

Gauze/sponge, Internal

BIOSEAL

The following data is part of a premarket notification filed by Bioseal with the FDA for Intestinal Sponges.

Pre-market Notification Details

Device IDK882710
510k NumberK882710
Device Name:INTESTINAL SPONGES
ClassificationGauze/sponge, Internal
Applicant BIOSEAL 350 NORTH PALM Brea,  CA  92621
ContactWilliam L Runion
CorrespondentWilliam L Runion
BIOSEAL 350 NORTH PALM Brea,  CA  92621
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-27
Decision Date1988-08-03

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