SECURET DRAPE & INSTRUMENT RETAINER/INCL

Antisera, All Types, Klebsiella Spp.

RITMED, INC.

The following data is part of a premarket notification filed by Ritmed, Inc. with the FDA for Securet Drape & Instrument Retainer/incl.

Pre-market Notification Details

Device IDK830276
510k NumberK830276
Device Name:SECURET DRAPE & INSTRUMENT RETAINER/INCL
ClassificationAntisera, All Types, Klebsiella Spp.
Applicant RITMED, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGTC  
CFR Regulation Number866.3340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-25
Decision Date1983-03-29

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