Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
510(k) Number |
K151112 |
Device Name |
Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design |
Applicant |
ANGIOTECH |
100 DENNIS DRIVE |
READING,
PA
19606
|
|
Applicant Contact |
HILARY WELLS |
Correspondent |
ANGIOTECH |
100 DENNIS DRIVE |
READING,
PA
19606
|
|
Correspondent Contact |
HILARY WELLS |
Regulation Number | 878.5010
|
Classification Product Code |
|
Date Received | 04/28/2015 |
Decision Date | 09/10/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|