Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K072645 |
Device Name |
UNIGLACTIN |
Applicant |
UNITED MEDICAL INDUSTRIES CO. LTD. |
3RD INDUSTRIAL CITY |
P.O. BOX 51871 |
RIYADH, CENTRAL PROVINCE,
SA
11553
|
|
Applicant Contact |
R RAGHUNATHAN |
Correspondent |
UNITED MEDICAL INDUSTRIES CO. LTD. |
3RD INDUSTRIAL CITY |
P.O. BOX 51871 |
RIYADH, CENTRAL PROVINCE,
SA
11553
|
|
Correspondent Contact |
R RAGHUNATHAN |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 09/18/2007 |
Decision Date | 11/07/2007 |
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
|
|
|