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 K191741
Device Name Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
Applicant
Intertape Polymer Inc.
100 Paramount Dr Suite 300
Sarasota,  FL  34232
Applicant Contact Michael Bryant
Correspondent
Highpower Validation Testing & Lab Service's Inc.
125 Highpower Road
Rochester,  NY  14623
Correspondent Contact Gary J. Socola
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received07/01/2019
Decision Date 08/02/2019
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
-
-