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 Probe, Uptake, Nuclear
510(k) Number K915279
Device Name NEOPROBE PORTABLE RADIOSCOPE DETECTOR
Applicant
Neoprobe Corp.
855 W. Fifth Ave.
Columbus,  OH  43212
Applicant Contact ROGER P.KAMINSKI
Correspondent
Neoprobe Corp.
855 W. Fifth Ave.
Columbus,  OH  43212
Correspondent Contact ROGER P.KAMINSKI
Regulation Number892.1320
Classification Product Code
IZD  
Date Received11/25/1991
Decision Date 06/10/1992
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
-
-