• 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 screen, leaded, operator radiation protector
510(k) Number K850814
Device Name MODULAR X-RAY BARRIERS
Applicant
VICTOREEN, INC.
100 voice rd.
carle place,  NY  11514
Applicant Contact glasser
Correspondent
VICTOREEN, INC.
100 voice rd.
carle place,  NY  11514
Correspondent Contact glasser
Regulation Number892.6500
Classification Product Code
EAK  
Date Received02/28/1985
Decision Date 04/10/1985
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-