FDA 510(k) Application Details - K992159

Device Classification Name

  More FDA Info for this Device
510(K) Number K992159
Device Name SURGISIS SLING
Applicant COOK BIOTECH, INC.
3055 KENT AVE.
WEST LAFAYETTE, IN 47906-1076 US
Other 510(k) Applications for this Company
Contact NEAL E FEARNOT
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 06/25/1999
Decision Date 09/23/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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