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 Lithotriptor, Biliary Mechanical
510(k) Number K903529
Device Name BML SERIES
Applicant
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Applicant Contact DANIEL J DILLON
Correspondent
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Correspondent Contact DANIEL J DILLON
Regulation Number876.4500
Classification Product Code
LQC  
Date Received08/06/1990
Decision Date 01/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-