FDA.report

510(k) K232658

Device
T-Top 10 & T-Top T-Top 11
Applicant
Tuttnauer U.S.A Co, Ltd.
510(k) number
K232658
Product code
FLE
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-27
Date received
2023-08-31
Regulation
880.6880
Classification name
Sterilizer, Steam
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Jonathan Lane
Address
25 Power Dr. Hauppauge New York NY US 11788 11788

FDA Registration Numbers

Source Documents

510(k) summary PDF

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