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 Laparoscope, General & Plastic Surgery
510(k) Number K974336
Device Name CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
Applicant
J-Lloyd Medical, Inc.
415 Commerce Ln., Suite 6
West Berlin,  NJ  08091
Applicant Contact JAMES L SKAGGS
Correspondent
J-Lloyd Medical, Inc.
415 Commerce Ln., Suite 6
West Berlin,  NJ  08091
Correspondent Contact JAMES L SKAGGS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/18/1997
Decision Date 02/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-