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 K111150
Device Name STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
Applicant
STERITEC PRODUCTS MFG. CO., INC.
74 INVERNESS DRIVE EAST
ENGLEWOOD,  CO  80112
Applicant Contact JONATHAN RUTIGLIANO
Correspondent
STERITEC PRODUCTS MFG. CO., INC.
74 INVERNESS DRIVE EAST
ENGLEWOOD,  CO  80112
Correspondent Contact JONATHAN RUTIGLIANO
Regulation Number880.2800
Classification Product Code
FRC  
Date Received04/25/2011
Decision Date 07/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-