STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI

Wrap, Sterilization

CASE MEDICAL, INC.

The following data is part of a premarket notification filed by Case Medical, Inc. with the FDA for Steritite Perforated Base Rigid Reusable Sterilization Container System With Scf02-polypropylene Non-woven Disposable Fi.

Pre-market Notification Details

Device IDK030853
510k NumberK030853
Device Name:STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI
ClassificationWrap, Sterilization
Applicant CASE MEDICAL, INC. 65 RAILROAD AVE. Ridgefield,  NJ  07657 -0402
ContactMarcia Frieze
CorrespondentTania Lupu
CASE MEDICAL, INC. 65 RAILROAD AVE. Ridgefield,  NJ  07657 -0402
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-18
Decision Date2003-03-21
Summary:summary

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