FDA.reportPublic FDA data

510(k) K210836

Device
InstruSafe Instrument Protection System
Applicant
Summitt Medical, LLC
510(k) number
K210836
Product code
KCT
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-30
Date received
2021-03-22
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

Applicant Contact#

Contact
Debra Kridner
Address
815 Vikings Pkwy., Suite 100 St. Paul MN US 55121 55121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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