Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K133019 |
Device Name |
FIBERION OPHTHALMIC ENDOLASER PROBE |
Applicant |
EMTRON ELEKTRONIK VE MEKANIK SANAYI VE TICARET LIM |
BEBEK YOLU SOKAGI 23/3 ETILER |
ISTANBUL,
TR
34337
|
|
Applicant Contact |
MEHMET MELEK |
Correspondent |
EMTRON ELEKTRONIK VE MEKANIK SANAYI VE TICARET LIM |
BEBEK YOLU SOKAGI 23/3 ETILER |
ISTANBUL,
TR
34337
|
|
Correspondent Contact |
MEHMET MELEK |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 09/26/2013 |
Decision Date | 02/20/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|