Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyamide
|
510(k) Number |
K042284 |
Device Name |
UNIMIDE |
Applicant |
UNITED MEDICAL INDUSTRIES CO. LTD. |
3RD INDUSTRIAL CITY |
SANAYYA, OPPOSITE TO OBAIKAN |
RIYADH, CENTRAL PROVINCE,
SA
11553
|
|
Applicant Contact |
MOHAMMED AZEEZ |
Correspondent |
UNITED MEDICAL INDUSTRIES CO. LTD. |
3RD INDUSTRIAL CITY |
SANAYYA, OPPOSITE TO OBAIKAN |
RIYADH, CENTRAL PROVINCE,
SA
11553
|
|
Correspondent Contact |
MOHAMMED AZEEZ |
Regulation Number | 878.5020
|
Classification Product Code |
|
Date Received | 08/24/2004 |
Decision Date | 12/03/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|