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 K854902
Device Name SURGICOT STEAM TEST PACK
Applicant
SURGICOT, INC.
55 KENNEDY DR.
SMITHTOWN,  NY  11787
Applicant Contact JAMES BROWN
Correspondent
SURGICOT, INC.
55 KENNEDY DR.
SMITHTOWN,  NY  11787
Correspondent Contact JAMES BROWN
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/09/1985
Decision Date 05/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-