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 catheter, urethral
510(k) Number K211436
Device Name Intermittent Catheter (Not Finalized)
Applicant
Hollister Incorporated
2000 Hollister Drive
Libertyville,  IL  60048
Applicant Contact Michelle Schiltz-Taing
Correspondent
Hollister Incorporated
2000 Hollister Drive
Libertyville,  IL  60048
Correspondent Contact Michelle Schiltz-Taing
Regulation Number876.5130
Classification Product Code
GBM  
Date Received05/10/2021
Decision Date 01/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-