FDA 510(k) Application Details - K980722

Device Classification Name Cassette, Radiographic Film

  More FDA Info for this Device
510(K) Number K980722
Device Name Cassette, Radiographic Film
Applicant IMATION CORP.
1 IMATION PLACE
OAKDALE, MN 55128 US
Other 510(k) Applications for this Company
Contact STEPHEN G SLAVENS
Other 510(k) Applications for this Contact
Regulation Number 892.1850

  More FDA Info for this Regulation Number
Classification Product Code IXA
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 02/24/1998
Decision Date 03/23/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact