SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

SKLAR CORP.

The following data is part of a premarket notification filed by Sklar Corp. with the FDA for Sklarlite Rigid Sterilization Container System.

Pre-market Notification Details

Device IDK091720
510k NumberK091720
Device Name:SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant SKLAR CORP. 55 Northern Blvd Suite 200 Great Neck,  NY  11021
ContactNatalya Valerio
CorrespondentNatalya Valerio
SKLAR CORP. 55 Northern Blvd Suite 200 Great Neck,  NY  11021
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-11
Decision Date2010-04-09
Summary:summary

NIH GUDID Devices

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