510(k) K241836

Device
Kem Medical Lead-free Chemical Indicators for Steam Sterilization
Applicant
Kem Medical Products Corporation
510(k) number
K241836
Product code
JOJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-30
Date received
2024-06-25
Regulation
880.2800
Classification name
Indicator, Physical/Chemical Sterilization Process
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
Lisa Kruger
Address
400 Oser Ave. Suite 2400 Hauppauge NY US 11788 11788

FDA Registration Numbers

Source Documents

510(k) summary PDF

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