Device Classification Name |
suture, nonabsorbable, synthetic, polypropylene
|
510(k) Number |
K903643 |
Device Name |
DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE |
Applicant |
DEKNATEL, INC. |
KILOMETER 9 CARRETERA |
SAN JOSE-HEREDIA,
CR
|
|
Applicant Contact |
HARRY SAVARD |
Correspondent |
DEKNATEL, INC. |
KILOMETER 9 CARRETERA |
SAN JOSE-HEREDIA,
CR
|
|
Correspondent Contact |
HARRY SAVARD |
Regulation Number | 878.5010
|
Classification Product Code |
|
Date Received | 08/10/1990 |
Decision Date | 12/24/1990 |
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
|
|
|