FDA 510(k) Application Details - K984151

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

  More FDA Info for this Device
510(K) Number K984151
Device Name Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Applicant MILL POND, INC.
ONE STILES ROAD, SUITE 104
SALEM, NH 03079 US
Other 510(k) Applications for this Company
Contact GREGORY E SANCOFF
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 11/19/1998
Decision Date 04/28/1999
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