FDA 510(k) Application Details - K823591

Device Classification Name Pump, Breast, Non-Powered

  More FDA Info for this Device
510(K) Number K823591
Device Name Pump, Breast, Non-Powered
Applicant BURDITT & CALKINS-SIEMENS-ELEMA

, US
Other 510(k) Applications for this Company
Regulation Number 884.5150

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

  More FDA Info for this Product Code
Date Received 12/06/1982
Decision Date 12/28/1982
Decision SE - Substantially Equivalent
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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