• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K121593
Models 1496V, 41482V
Device Name 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK
Original Applicant
3M COMPANY
3m center, bldg. 275-5w-06
st. paul,  MN  55144 1000
Original Contact suzanne leung
Regulation Number880.2800
Classification Product Code
FRC  
Date Received05/31/2012
Decision Date 03/15/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-