Device Classification Name |
Staple, Implantable
|
510(k) Number |
K120373 |
Device Name |
INSORB ABSORBALBE STAPLE |
Applicant |
INCISIVE SURGICAL, INC. |
14405 21ST AVE N. |
SUITE 130 |
PLYMOUTH,
MN
55447
|
|
Applicant Contact |
DAVID HERRIDGE |
Correspondent |
INCISIVE SURGICAL, INC. |
14405 21ST AVE N. |
SUITE 130 |
PLYMOUTH,
MN
55447
|
|
Correspondent Contact |
DAVID HERRIDGE |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 02/06/2012 |
Decision Date | 03/16/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|