FDA.report

510(k) K231893

Device
LOWTEM Crystal 120
Applicant
Lowtem Co., Ltd.
510(k) number
K231893
Product code
MLR
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-18
Date received
2023-06-28
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
Suyeon Lee
Address
100-2, Cheombok-Ro, Dong-Gu Daegu-Si KR 41061 41061

FDA Registration Numbers

Source Documents

510(k) summary PDF

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