FDA 510(k) Application Details - K861019

Device Classification Name Screen, Leaded, Operator Radiation Protector

  More FDA Info for this Device
510(K) Number K861019
Device Name Screen, Leaded, Operator Radiation Protector
Applicant PHASE ONE DISIGN CO.
1455-I E. FRANCISCO BLVD.
SAN RAFAEL, CA US
Other 510(k) Applications for this Company
Contact MELVIN MAGLIOCCO
Other 510(k) Applications for this Contact
Regulation Number 892.6500

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

  More FDA Info for this Product Code
Date Received 03/18/1986
Decision Date 04/02/1986
Decision SE - Substantially Equivalent
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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