Device Classification Name |
Suture, Absorbable, Natural
|
510(k) Number |
K930738 |
Device Name |
SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC |
Applicant |
DEKNATEL, INC. |
KILOMETER 9 CARRETERA |
SAN JOSE-HEREDIA,
CR
|
|
Applicant Contact |
HARRY C SAVARD |
Correspondent |
DEKNATEL, INC. |
KILOMETER 9 CARRETERA |
SAN JOSE-HEREDIA,
CR
|
|
Correspondent Contact |
HARRY C SAVARD |
Regulation Number | 878.4830
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/12/1993 |
Decision Date | 07/26/1994 |
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
|
Recalls |
CDRH Recalls
|
|
|