FDA 510(k) Application Details - K052626

Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)

  More FDA Info for this Device
510(K) Number K052626
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant HAEMONETICS CORP.
400 WOOD ROAD
BRAINTREE, MA 02184-9114 US
Other 510(k) Applications for this Company
Contact GABRIEL J MURACA
Other 510(k) Applications for this Contact
Regulation Number 878.4780

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

  More FDA Info for this Product Code
Date Received 09/23/2005
Decision Date 10/05/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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