Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K122734 |
Device Name |
AESCULAP NOVOSYN ABSORBABLE SUTURE |
Applicant |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Applicant Contact |
KATHY A RACOSKY |
Correspondent |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Correspondent Contact |
KATHY A RACOSKY |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 09/06/2012 |
Decision Date | 12/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|