FDA 510(k) Application Details - K143151

Device Classification Name Dressing, Wound, Drug

  More FDA Info for this Device
510(K) Number K143151
Device Name Dressing, Wound, Drug
Applicant BSN MEDICAL GMBH
QUICKBORNSTRASSE 24
HAMBURG 20253 DE
Other 510(k) Applications for this Company
Contact MARTIN SPENGLER
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 11/03/2014
Decision Date 01/26/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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