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, Gonadal
510(k) Number K930763
Device Name FIGLEAF SHIELD
Applicant
Byers Industries, Inc.
6955 SW Sandburg St.
Portland,  OR  97223
Applicant Contact CHARLES J STORM
Correspondent
Byers Industries, Inc.
6955 SW Sandburg St.
Portland,  OR  97223
Correspondent Contact CHARLES J STORM
Regulation Number892.6500
Classification Product Code
IWT  
Date Received02/12/1993
Decision Date 05/17/1993
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
-
-