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 Screen, Leaded, Operator Radiation Protector
510(k) Number K896949
Device Name MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS
Applicant
Innovative Products Mfg.
Box 447
248 Dodge Ave.
East Haven,  CT  06512
Applicant Contact KENNEY, SR
Correspondent
Innovative Products Mfg.
Box 447
248 Dodge Ave.
East Haven,  CT  06512
Correspondent Contact KENNEY, SR
Regulation Number892.6500
Classification Product Code
EAK  
Date Received12/13/1989
Decision Date 02/16/1990
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
-
-