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 Block, Beam-Shaping, Radiation Therapy
510(k) Number K010172
Device Name LEAD BLOCKS
Applicant
Arplay Medical S.A.
1, Route De Citeaux
Izeure, Cote D'Or,  FR 21110
Applicant Contact RICHARD BORGI
Correspondent
Arplay Medical S.A.
1, Route De Citeaux
Izeure, Cote D'Or,  FR 21110
Correspondent Contact RICHARD BORGI
Regulation Number892.5710
Classification Product Code
IXI  
Date Received01/18/2001
Decision Date 04/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-