Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyamide
|
510(k) Number |
K905286 |
Device Name |
IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES |
Applicant |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
C/O MEDICAL DEVICE INSPECTION |
55 NORTHERN BOULEVARD, STE 301 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
ALAN P SCHWARTZ |
Correspondent |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
C/O MEDICAL DEVICE INSPECTION |
55 NORTHERN BOULEVARD, STE 301 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
ALAN P SCHWARTZ |
Regulation Number | 878.5020
|
Classification Product Code |
|
Date Received | 11/26/1990 |
Decision Date | 02/11/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|