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 K122024
Device Name SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR
Applicant
SPS MEDICAL SUPPLY CORP.
6789 W Henrietta Rd
Industry,  NY  14543
Applicant Contact GARY J SOCOLA
Correspondent
SPS MEDICAL SUPPLY CORP.
6789 W Henrietta Rd
Industry,  NY  14543
Correspondent Contact GARY J SOCOLA
Regulation Number880.2800
Classification Product Code
FRC  
Date Received07/11/2012
Decision Date 11/26/2013
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
-
-