FDA 510(k) Application Details - K010037

Device Classification Name Instrument, Biopsy

  More FDA Info for this Device
510(K) Number K010037
Device Name Instrument, Biopsy
Applicant DAUM GMBH
P.O. BOX 4341
CROFTON, MD 21114 US
Other 510(k) Applications for this Company
Contact CHRISTINA SMITH
Other 510(k) Applications for this Contact
Regulation Number 876.1075

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

  More FDA Info for this Product Code
Date Received 01/04/2001
Decision Date 03/22/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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