SterilContainer With PrimeLine Pro Lid

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 Sterilcontainer With Primeline Pro Lid.

Pre-market Notification Details

Device IDK172850
510k NumberK172850
Device Name:SterilContainer With PrimeLine Pro Lid
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
ContactLisa Boyle
CorrespondentLisa Boyle
Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-20
Decision Date2017-11-17
Summary:summary

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