Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K102916 |
Device Name |
G-CATH TISSUE ANCHOR DELIVERY CATHETER |
Applicant |
USGI MEDICAL |
1140 CALLE CORDILLERA |
SAN CLEMENTE,
CA
92673
|
|
Applicant Contact |
MARY L MOONEY |
Correspondent |
USGI MEDICAL |
1140 CALLE CORDILLERA |
SAN CLEMENTE,
CA
92673
|
|
Correspondent Contact |
MARY L MOONEY |
Regulation Number | 878.5000
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/01/2010 |
Decision Date | 10/20/2010 |
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
|