Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyamide
|
510(k) Number |
K052900 |
Device Name |
QUILL NONABSORBABLE NYLON BARBED SUTURE |
Applicant |
QUILL MEDICAL, INC. |
2505 MERIDIAN PARKWAY |
SUITE 150 |
RESEARCH TRIANGLE PARK,
NC
27713
|
|
Applicant Contact |
LOIS V SMART |
Correspondent |
QUILL MEDICAL, INC. |
2505 MERIDIAN PARKWAY |
SUITE 150 |
RESEARCH TRIANGLE PARK,
NC
27713
|
|
Correspondent Contact |
LOIS V SMART |
Regulation Number | 878.5020
|
Classification Product Code |
|
Date Received | 10/14/2005 |
Decision Date | 11/28/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|