Device Classification Name |
Suture, Surgical, Absorbable, Polydioxanone
|
510(k) Number |
K041048 |
Device Name |
POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE |
Applicant |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Applicant Contact |
CAROLANN KOTULA |
Correspondent |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
CAROLANN KOTULA |
Regulation Number | 878.4840
|
Classification Product Code |
|
Date Received | 04/22/2004 |
Decision Date | 06/04/2004 |
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
|