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 Cassette, Radiographic Film
510(k) Number K021903
Device Name KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
Applicant
Eastman Kodak Company
1669 Lake Ave.
Rochester,  NY  14652
Applicant Contact PATRICIA B LANZONI
Correspondent
Eastman Kodak Company
1669 Lake Ave.
Rochester,  NY  14652
Correspondent Contact PATRICIA B LANZONI
Regulation Number892.1850
Classification Product Code
IXA  
Date Received06/10/2002
Decision Date 07/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-