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 Indicator, Physical/Chemical Sterilization Process
510(k) Number K241836
Device Name Kem Medical Lead-free Chemical Indicators for Steam Sterilization
Applicant
Kem Medical Products Corporation
400 Oser Ave.
Suite 2400
Hauppauge,  NY  11788
Applicant Contact Lisa Kruger
Correspondent
Kem Medical Products Corporation
400 Oser Ave.
Suite 2400
Hauppauge,  NY  11788
Correspondent Contact Lisa Kruger
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received06/25/2024
Decision Date 09/30/2024
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
-
-