Device Classification Name |
Staple, Implantable
|
510(k) Number |
K873748 |
Device Name |
RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT |
Applicant |
DEKNATEL, INC. |
2300 MARCUS AVE. |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
OROFINO |
Correspondent |
DEKNATEL, INC. |
2300 MARCUS AVE. |
LAKE SUCCESS,
NY
11042
|
|
Correspondent Contact |
OROFINO |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 09/16/1987 |
Decision Date | 01/06/1988 |
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
|
|
|