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 K901185
Device Name FOLEY CATHETER INSERTION TRAY (10CC)
Applicant
Orion Life Systems, Inc.
124 Messner Dr.
Wheeling,  IL  60090
Applicant Contact JOHN L LAEMMAR
Correspondent
Orion Life Systems, Inc.
124 Messner Dr.
Wheeling,  IL  60090
Correspondent Contact JOHN L LAEMMAR
Regulation Number876.5130
Classification Product Code
FCM  
Date Received03/13/1990
Decision Date 07/20/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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
Recalls CDRH Recalls
-
-