Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Sterilizer, Chemical
510(k) Number K231893
Device Name LOWTEM Crystal 120
Applicant
Lowtem Co., Ltd.
100-2, Cheombok-Ro, Dong-Gu
Daegu-Si,  KR 41061
Applicant Contact Suyeon Lee
Correspondent
Bt Solutions, Inc.
Unit 904, Eonju-Ro 86-Gil 5, Gangnam-Gu
Seoul,  KR 06210
Correspondent Contact Do Hyun Kim
Regulation Number880.6860
Classification Product Code
MLR  
Date Received06/28/2023
Decision Date 09/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-