Device Classification Name |
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
More FDA Info for this Device |
510(K) Number |
K081060 |
Device Name |
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
Applicant |
CORE ESSENCE ORTHOPAEDICS, LLC
301 OXFORD VALLEY RD.
SUITE 905B
YARDLEY, PA 19067 US
Other 510(k) Applications for this Company
|
Contact |
SHAWN T HUXEL
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 |
04/14/2008 |
Decision Date |
12/24/2008 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
SU - General & Plastic Surgery |
Review Advisory Committee |
SU - General & Plastic Surgery |
Statement / Summary / Purged Status |
Summary |
Type |
Abbreviated |
Reviewed By Third Party |
N |
Expedited Review |
|