Device Classification Name |
suture, absorbable, natural
|
510(k) Number |
K020597 |
Device Name |
SERRALGUT |
Applicant |
SERRAL, S.A. DE C.V. |
5251-18 JOHN TYLER HWY, |
SUITE 167 |
WILLIAMSBURG,
VA
23185
|
|
Applicant Contact |
SCOTT HENDERSON |
Correspondent |
SERRAL, S.A. DE C.V. |
5251-18 JOHN TYLER HWY, |
SUITE 167 |
WILLIAMSBURG,
VA
23185
|
|
Correspondent Contact |
SCOTT HENDERSON |
Regulation Number | 878.4830
|
Classification Product Code |
|
Date Received | 02/22/2002 |
Decision Date | 08/14/2002 |
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
|
|
|