FDA 510(k) Application Details - K020597

Device Classification Name Suture, Absorbable, Natural

  More FDA Info for this Device
510(K) Number K020597
Device Name Suture, Absorbable, Natural
Applicant SERRAL, S.A. DE C.V.
5251-18 JOHN TYLER HWY,
SUITE 167
WILLIAMSBURG, VA 23185 US
Other 510(k) Applications for this Company
Contact SCOTT HENDERSON
Other 510(k) Applications for this Contact
Regulation Number 878.4830

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

  More FDA Info for this Product Code
Date Received 02/22/2002
Decision Date 08/14/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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