510(k) K233762

Device
SteroScope® Sterilization Technology System
Applicant
Ideate Medical, Inc.
510(k) number
K233762
Product code
MLR
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-27
Date received
2023-11-24
Regulation
880.6860
Classification name
Sterilizer, Chemical
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
William Wong
Address
2821 N. Ballas Rd. C55 St. Louis MO US 63131 63131

FDA Registration Numbers

Source Documents

510(k) summary PDF

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