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 Central Control Unit
510(k) Number K022270
Device Name MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
Applicant
Olympus Optical Co., Ltd.
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus Optical Co., Ltd.
Two Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact LAURA STORMS-TYLER
Regulation Number876.1500
Classification Product Code
ODA  
Date Received07/15/2002
Decision Date 08/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-