Device Classification Name |
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
More FDA Info for this Device |
510(K) Number |
K013059 |
Device Name |
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
Applicant |
STONY BROOK SURGICAL INNOVATIONS, INC.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
Other 510(k) Applications for this Company
|
Contact |
SUSAN D GOLDSTEIN-FALK
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 |
09/11/2001 |
Decision Date |
10/22/2001 |
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 |
|