FDA 510(k) Application Details - K032156

Device Classification Name Accelerator, Linear, Medical

  More FDA Info for this Device
510(K) Number K032156
Device Name Accelerator, Linear, Medical
Applicant WFR/AQUAPLAST CORP.
30 LAWLINS PARK
WYCKOFF, NJ 07481 US
Other 510(k) Applications for this Company
Contact J. DAMON KIRK
Other 510(k) Applications for this Contact
Regulation Number 892.5050

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

  More FDA Info for this Product Code
Date Received 07/14/2003
Decision Date 09/02/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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