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 K141642
Device Name VAPRO INTERMITTENT CATHETER
Applicant
Hollister Incorporated
2000 Hollister Dr.
Libertyville,  IL  60048
Applicant Contact JEANNE LEE
Correspondent
Hollister Incorporated
2000 Hollister Dr.
Libertyville,  IL  60048
Correspondent Contact JEANNE LEE
Regulation Number876.5130
Classification Product Code
GBM  
Date Received06/19/2014
Decision Date 08/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-