Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K072859 |
Device Name |
ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES |
Applicant |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Applicant Contact |
ALAN P SCHWARTZ |
Correspondent |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
ALAN P SCHWARTZ |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 10/05/2007 |
Decision Date | 05/23/2008 |
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
|