Device Classification Name |
Endoscopic Tissue Approximation Device
|
510(k) Number |
K994087 |
Device Name |
SUPERSTITCH |
Applicant |
SUTURA, INC. |
17080 NEWHOPE ST. |
FOUNTAIN VALLEY,
CA
92708
|
|
Applicant Contact |
DAVE BARRY |
Correspondent |
SUTURA, INC. |
17080 NEWHOPE ST. |
FOUNTAIN VALLEY,
CA
92708
|
|
Correspondent Contact |
DAVE BARRY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/03/1999 |
Decision Date | 03/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|