LAP SPONGE

Gauze, External (with Drug/biologic/animal Source Material)

CARAPACE, INC.

The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Lap Sponge.

Pre-market Notification Details

Device IDK782107
510k NumberK782107
Device Name:LAP SPONGE
ClassificationGauze, External (with Drug/biologic/animal Source Material)
Applicant CARAPACE, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGER  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-12-19
Decision Date1979-02-16

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