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 K962073
Device Name URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
Applicant
Continental Medical Laboratories, Inc.
817 W. Mohr Ave.
P.O. Box 306
Waterford,  WI  53185
Applicant Contact JOSEPH DUNN
Correspondent
Continental Medical Laboratories, Inc.
817 W. Mohr Ave.
P.O. Box 306
Waterford,  WI  53185
Correspondent Contact JOSEPH DUNN
Regulation Number876.5130
Classification Product Code
FCM  
Date Received05/28/1996
Decision Date 06/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-