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 System, Therapeutic, X-Ray
510(k) Number K110590
Device Name INTRABEAM NEEDLE APPLICATOR
Applicant
Carl Zeiss Surgical GmbH
5160 Hacienda Dr.
Dublin,  CA  94568
Applicant Contact JUDITH A BRIMACOMBE, MA
Correspondent
Carl Zeiss Surgical GmbH
5160 Hacienda Dr.
Dublin,  CA  94568
Correspondent Contact JUDITH A BRIMACOMBE, MA
Regulation Number892.5900
Classification Product Code
JAD  
Date Received03/02/2011
Decision Date 04/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-