NEURO SPONGE

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

SURGICOT, INC.

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

Pre-market Notification Details

Device IDK840541
510k NumberK840541
Device Name:NEURO SPONGE
ClassificationGauze, External (with Drug/biologic/animal Source Material)
Applicant SURGICOT, 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 Received1984-02-08
Decision Date1984-04-23

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