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 Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K922440
Device Name STERIKING, SEE & PEEL
Applicant
Cox Sterile Products, Inc.
5115 Mckinney Ave., Suite C
Dallas,  TX  75205
Applicant Contact MARK J GAINOR
Correspondent
Cox Sterile Products, Inc.
5115 Mckinney Ave., Suite C
Dallas,  TX  75205
Correspondent Contact MARK J GAINOR
Regulation Number880.6850
Classification Product Code
KCT  
Date Received05/22/1992
Decision Date 09/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-