Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K073493 |
Device Name |
HEPATOSTAT SET |
Applicant |
VYGON CORP. |
2495 GENERAL ARMISTEAD AVE |
NORRISTOWN,
PA
19403
|
|
Applicant Contact |
COURTNEY SMITH |
Correspondent |
VYGON CORP. |
2495 GENERAL ARMISTEAD AVE |
NORRISTOWN,
PA
19403
|
|
Correspondent Contact |
COURTNEY SMITH |
Regulation Number | 878.4493
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/12/2007 |
Decision Date | 05/06/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|