FDA 510(k) Application Details - K955643

Device Classification Name Processor, Radiographic-Film, Automatic, Dental

  More FDA Info for this Device
510(K) Number K955643
Device Name Processor, Radiographic-Film, Automatic, Dental
Applicant DENOPTIX, INC.
270 SANTA ANA CT.
SUNNYVALE, CA 94086 US
Other 510(k) Applications for this Company
Contact JOSEPH RIMSA
Other 510(k) Applications for this Contact
Regulation Number 892.1900

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

  More FDA Info for this Product Code
Date Received 12/12/1995
Decision Date 03/01/1996
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