• 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 sterilization wrap containers, trays, cassettes & other accessories
510(k) Number K120947
Model THS-01513
Device Name THS INSTRUMENT TRAY
Original Applicant
HOLOGIC, INC.
250 campus drive
marlborough,  MA  01752
Original Contact sarah fairfield
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/29/2012
Decision Date 10/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-