FDA 510(k) Application Details - K991073

Device Classification Name Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

  More FDA Info for this Device
510(K) Number K991073
Device Name Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Applicant CARDIO THORACIC SYSTEMS
10600 N. TANTAU AVE.
CUPERTINO, CA 95014-0739 US
Other 510(k) Applications for this Company
Contact MICHAEL J BILLIG
Other 510(k) Applications for this Contact
Regulation Number 878.4495

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

  More FDA Info for this Product Code
Date Received 03/31/1999
Decision Date 07/30/1999
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