Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K061796 |
Device Name |
HEPATOSTAT SET, MODEL 760X |
Applicant |
VYGON CORP. |
30833 NORTHWESTERS HWY |
SUITE 121 |
FARMINGTON HILLS,
MI
48334
|
|
Applicant Contact |
STEPHEN GOLDNER |
Correspondent |
VYGON CORP. |
30833 NORTHWESTERS HWY |
SUITE 121 |
FARMINGTON HILLS,
MI
48334
|
|
Correspondent Contact |
STEPHEN GOLDNER |
Regulation Number | 878.4493
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/26/2006 |
Decision Date | 11/02/2006 |
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
|