ReNew Sterilization Trays(Catalog #3708 And #3709)

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

MICROLINE SURGICAL, INC.

The following data is part of a premarket notification filed by Microline Surgical, Inc. with the FDA for Renew Sterilization Trays(catalog #3708 And #3709).

Pre-market Notification Details

Device IDK152745
510k NumberK152745
Device Name:ReNew Sterilization Trays(Catalog #3708 And #3709)
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant MICROLINE SURGICAL, INC. 50 DUNHAM ROAD, SUITE 1500 Beverly,  MA  01915
ContactAnu Gaur
CorrespondentAnu Gaur
MICROLINE SURGICAL, INC. 50 DUNHAM ROAD, SUITE 1500 Beverly,  MA  01915
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-23
Decision Date2016-05-12
Summary:summary

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