FDA 510(k) Application Details - K972703

Device Classification Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered

  More FDA Info for this Device
510(K) Number K972703
Device Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Applicant B. BRAUN MEDICAL, INC.
824 12TH AVE.
BETHLEHEM, PA 18018 US
Other 510(k) Applications for this Company
Contact MARK S ALSBERGE
Other 510(k) Applications for this Contact
Regulation Number 878.4680

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

  More FDA Info for this Product Code
Date Received 07/18/1997
Decision Date 10/01/1997
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 N
Expedited Review



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