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 bag, urine collection, leg, for external use, sterile
510(k) Number K772402
Device Name QUADRIPLEGIC URINARY DRAINAGE VALVE
Applicant
FRED SAMMONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FRED SAMMONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received12/27/1977
Decision Date 01/26/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-