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 Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
510(k) Number K950729
FOIA Releasable 510(k) K950729
Device Name OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)
Applicant
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042 -1179
Applicant Contact BARRY SANDS
Correspondent
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042 -1179
Correspondent Contact BARRY SANDS
Regulation Number876.1500
Classification Product Code
ODD  
Date Received02/16/1995
Decision Date 03/17/1995
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
Recalls CDRH Recalls
-
-