Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
510(k) Number |
K012865 |
Device Name |
SUPERSTITCH VASCULAR SUTURING DEVICE |
Applicant |
SUTURA, INC. |
17080 NEWHOPE ST. |
FOUNTAIN VALLEY,
CA
92708
|
|
Applicant Contact |
JAMES BONDS |
Correspondent |
SUTURA, INC. |
17080 NEWHOPE ST. |
FOUNTAIN VALLEY,
CA
92708
|
|
Correspondent Contact |
JAMES BONDS |
Regulation Number | 878.5010 |
Classification Product Code |
|
Date Received | 08/27/2001 |
Decision Date | 09/25/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|