Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K120170 |
Device Name |
PROCARE PLUS VITRECTOMY SYSTEM |
Applicant |
VISIONCARE DEVICES, INC. |
1246 REDWOOD BLVD. |
REDDING,
CA
96003
|
|
Applicant Contact |
KURTIS MONTEGNA |
Correspondent |
VISIONCARE DEVICES, INC. |
1246 REDWOOD BLVD. |
REDDING,
CA
96003
|
|
Correspondent Contact |
KURTIS MONTEGNA |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 01/19/2012 |
Decision Date | 05/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|