FDA.report

510(k) K192056

Device
JJ Series Container System
Applicant
Aesculap, Inc.
510(k) number
K192056
Product code
KCT  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-27
Date received
2019-08-01
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

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases