Device Classification Name |
fixation, non-absorbable or absorbable, for pelvic use
|
510(k) Number |
K130059 |
Device Name |
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP |
Applicant |
IBI ISRAEL BIOMEDICAL INNOVATIONS LTD. |
1914 J.N. PEASE PLACE |
CHARLOTTE,
NC
28262
|
|
Applicant Contact |
ELISSA BURG |
Correspondent |
IBI ISRAEL BIOMEDICAL INNOVATIONS LTD. |
1914 J.N. PEASE PLACE |
CHARLOTTE,
NC
28262
|
|
Correspondent Contact |
ELISSA BURG |
Regulation Number | 884.4530
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/10/2013 |
Decision Date | 07/29/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|