FDA.report

510(k) K182414

Device
Aesculap® SterilContainer(TM) S2 System
Applicant
Aesculap, Inc.
510(k) number
K182414
Product code
KCT  
Decision
Substantially Equivalent (SESE)
Decision date
2019-07-05
Date received
2018-09-04
Regulation
880.6850
Classification name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Sierra Mertz
Address
3773 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

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FDA Review

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