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 K893728
Device Name PINK CASSETTE CADDIE
Applicant
Medical Technique Instruments, Inc.
511 Sixth St. S.
Kirkland,  WA  98033
Applicant Contact LOU CASTAGNA
Correspondent
Medical Technique Instruments, Inc.
511 Sixth St. S.
Kirkland,  WA  98033
Correspondent Contact LOU CASTAGNA
Regulation Number892.1850
Classification Product Code
IXA  
Date Received05/17/1989
Decision Date 09/18/1989
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
-
-