Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
510(k) Number |
K180321 |
Device Name |
Aesculap Optilene Nonabsorbable 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 | 878.5010
|
Classification Product Code |
|
Date Received | 02/05/2018 |
Decision Date | 03/07/2018 |
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
|
|
|