TRIANGLE SPONGE

Gauze/sponge, Internal

ORMED MFG., INC.

The following data is part of a premarket notification filed by Ormed Mfg., Inc. with the FDA for Triangle Sponge.

Pre-market Notification Details

Device IDK880907
510k NumberK880907
Device Name:TRIANGLE SPONGE
ClassificationGauze/sponge, Internal
Applicant ORMED MFG., INC. 175 GREAT ARROW AVE. Buffalo,  NY  14207
ContactAnn M Johnson
CorrespondentAnn M Johnson
ORMED MFG., INC. 175 GREAT ARROW AVE. Buffalo,  NY  14207
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-03
Decision Date1988-03-17

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