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, Biological Sterilization Process
510(k) Number K182404
Device Name STERRAD VELOCITY Biological Indicator
Applicant
Advanced Sterilization Products (Asp)
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact Sun Choi
Correspondent
Advanced Sterilization Products (Asp)
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact Sun Choi
Regulation Number880.2800
Classification Product Code
FRC  
Date Received09/04/2018
Decision Date 12/27/2018
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
-
-