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 System, Applicator, Radionuclide, Manual
510(k) Number K974118
Device Name WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET
Applicant
Worldwide Medical Technologies, LLC
125 Main St., N.
Woodbury,  CT  06798
Applicant Contact GARY LAMOUREUX
Correspondent
Worldwide Medical Technologies, LLC
125 Main St., N.
Woodbury,  CT  06798
Correspondent Contact GARY LAMOUREUX
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received10/31/1997
Decision Date 01/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-