Device Classification Name |
suture, nonabsorbable, synthetic, polypropylene
|
510(k) Number |
K053482 |
Device Name |
SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW |
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 | 12/14/2005 |
Decision Date | 12/27/2005 |
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
|
|
|