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 Source, Calibration, Sealed, Nuclear
510(k) Number K812235
Device Name GOLD(AU 195) SPOT MARKER SOURCES
Applicant
Amersham Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Amersham Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1400
Classification Product Code
IXD  
Date Received08/11/1981
Decision Date 09/09/1981
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
-
-