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, Physical/Chemical Sterilization Process
510(k) Number K161024
Device Name Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape
Applicant
Canadian Technical Tape, Ltd.
455 Cote-Vertu Blvd.
Montreal,  CA h4n 1E8
Applicant Contact Howard Cohen
Correspondent
Highpower Validation and Testing Lab Services, Inc.
125 Highpower Rd.
Rochester,  NY  14623
Correspondent Contact Gary Socola
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received04/12/2016
Decision Date 06/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-