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 Biopsy Needle
510(k) Number K050503
Device Name SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
Applicant
Olympus Medical Systems Corporation
Two Corporate Center Dr.
Melville,  NY  11747 -9058
Applicant Contact LARUA STORMS-TYLER
Correspondent
Olympus Medical Systems Corporation
Two Corporate Center Dr.
Melville,  NY  11747 -9058
Correspondent Contact LARUA STORMS-TYLER
Regulation Number876.1075
Classification Product Code
FCG  
Date Received02/28/2005
Decision Date 05/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-