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 Accelerator, Linear, Medical
510(k) Number K982463
Device Name EXTRACRANIAL RADIOTHERAPY SYSTEM
Applicant
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact VIVIAN KELLY
Correspondent
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact VIVIAN KELLY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/15/1998
Decision Date 09/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-