Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
510(k) Number |
K020940 |
Device Name |
SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X |
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 | 03/22/2002 |
Decision Date | 04/17/2002 |
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
|
|
|