FDA 510(k) Application Details - K973132

Device Classification Name Clamp, Vascular

  More FDA Info for this Device
510(K) Number K973132
Device Name Clamp, Vascular
Applicant TZ MEDICAL, INC.
15858 S.W. UPPER BOONES FERRY
RD.
LAKE OSWEGO, OR 97035 US
Other 510(k) Applications for this Company
Contact BYRON ZAHLER
Other 510(k) Applications for this Contact
Regulation Number 870.4450

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

  More FDA Info for this Product Code
Date Received 08/21/1997
Decision Date 01/12/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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