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 Shield, Protective, Personnel
510(k) Number K896289
Device Name RADIATION PROTECTION APRON
Applicant
Infab Corp.
3651 Via Pescador
Camarillo,  CA  93012
Applicant Contact DON CUSICK
Correspondent
Infab Corp.
3651 Via Pescador
Camarillo,  CA  93012
Correspondent Contact DON CUSICK
Regulation Number892.6500
Classification Product Code
KPY  
Date Received10/31/1989
Decision Date 12/14/1989
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
-
-