Device Classification Name |
retractor
|
510(k) Number |
K151104 |
Device Name |
OTELO LL |
Applicant |
SPINEART |
INTERNATIONAL CENTER COINTRIN |
20 ROUTE DE PRE-BOIS, CP1813 |
Geneve,
CH
1215
|
|
Applicant Contact |
Franck Pennesi |
Correspondent |
SPINEART |
INTERNATIONAL CENTER COINTRIN |
20 ROUTE DE PRE-BOIS, CP1813 |
Geneve,
CH
1215
|
|
Correspondent Contact |
Franck Pennesi |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 04/24/2015 |
Decision Date | 01/06/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|