Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K153168 |
Device Name |
Bi-Blade Vitrectomy Cutter |
Applicant |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES |
557 MCCORMICK STREET |
SAN LEANDRO,
CA
94577
|
|
Applicant Contact |
Brenda Balletto |
Correspondent |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES |
557 MCCORMICK STREET |
SAN LEANDRO,
CA
94577
|
|
Correspondent Contact |
Brenda Balletto |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 11/02/2015 |
Decision Date | 04/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|