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 tray, catheterization, sterile urethral, with or without catheter (kit)
510(k) Number K961442
Device Name UNIVERSAL DRAINAGE TRAY
Applicant
CUSTOMED, INC.
CALLE IGUALDAD #7
FAJARDO,  PR  00738
Applicant Contact FELIX B SANTOS
Correspondent
CUSTOMED, INC.
CALLE IGUALDAD #7
FAJARDO,  PR  00738
Correspondent Contact FELIX B SANTOS
Regulation Number876.5130
Classification Product Code
FCM  
Date Received04/15/1996
Decision Date 05/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-