Device Classification Name |
Staple, Implantable
|
510(k) Number |
K881484 |
Device Name |
BIOFRAGMENTABLE BOWEL ANASTOMOSIS RING |
Applicant |
DAVIS & GECK, INC. |
AMERICAN CYNAMID COMPANY |
ONE CASPER STREET |
DANBURY,
CT
06810
|
|
Applicant Contact |
PELLETIER |
Correspondent |
DAVIS & GECK, INC. |
AMERICAN CYNAMID COMPANY |
ONE CASPER STREET |
DANBURY,
CT
06810
|
|
Correspondent Contact |
PELLETIER |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 04/08/1988 |
Decision Date | 05/04/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|