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, electro-hydraulic
510(k) Number K834228
Device Name LITHOTRIPTOR ELECTRODE 4.5F
Applicant
MONAGHAN MEDICAL CORP.
FRANKLYN BLDG RT. 9 NORTH
P.O. BOX 978
PLATTSBURGH,  NY  12901
Applicant Contact WILLIAM R SHENE
Correspondent
MONAGHAN MEDICAL CORP.
FRANKLYN BLDG RT. 9 NORTH
P.O. BOX 978
PLATTSBURGH,  NY  12901
Correspondent Contact WILLIAM R SHENE
Regulation Number876.4480
Classification Product Code
FFK  
Date Received12/06/1983
Decision Date 05/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-