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 Device, Incontinence, Urosheath Type, Sterile
510(k) Number K970465
Device Name BOUSER'S URINAL
Applicant
GENERAL POLYMERS
55 NORTHERN BLVD.
SUITE 410
GREAT NECK,  NY  10012
Applicant Contact MILTON N BENEKE JR.
Correspondent
GENERAL POLYMERS
55 NORTHERN BLVD.
SUITE 410
GREAT NECK,  NY  10012
Correspondent Contact MILTON N BENEKE JR.
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received02/07/1997
Decision Date 12/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-