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 High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
510(k) Number K192228
Device Name CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant
Applicant
Cs Medical, LLC
2179 E. Lyon Station Rd.
Creedmoor,  NC  27522
Applicant Contact Kendall Ashe
Correspondent
Cs Medical, LLC
2179 E. Lyon Station Rd.
Creedmoor,  NC  27522
Correspondent Contact Kendall Ashe
Regulation Number892.1570
Classification Product Code
PSW  
Subsequent Product Code
MED  
Date Received08/16/2019
Decision Date 04/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-