Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
510(k) Number |
K062125 |
Device Name |
SUPERSTITCH 5F, 12F, AND EL |
Applicant |
SUTURA, INC. |
555 THIRTEENTH ST. NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
GERARD J PRUD'HOMME |
Correspondent |
SUTURA, INC. |
555 THIRTEENTH ST. NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
GERARD J PRUD'HOMME |
Regulation Number | 878.5010 |
Classification Product Code |
|
Date Received | 07/25/2006 |
Decision Date | 10/19/2006 |
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
|
|
|