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 Unit, X-Ray, Extraoral With Timer
510(k) Number K932111
Device Name DENTAL X-RAY UNIT
Applicant
Castellini S.P.A.
40013 Castel Maggiore(Bo)
Via Saliceto 22
Italy,  IT
Applicant Contact LANZARINI
Correspondent
Castellini S.P.A.
40013 Castel Maggiore(Bo)
Via Saliceto 22
Italy,  IT
Correspondent Contact LANZARINI
Regulation Number872.1800
Classification Product Code
EHD  
Date Received05/03/1993
Decision Date 01/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-