JJ Series Container System

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Aesculap, Inc.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Jj Series Container System.

Pre-market Notification Details

Device IDK192056
510k NumberK192056
Device Name:JJ Series Container System
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
ContactSierra Mertz
CorrespondentSierra Mertz
Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-01
Decision Date2020-03-27

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