Device Classification Name |
Laser, Ophthalmic
|
510(k) Number |
K100019 |
Device Name |
PASCAL STREAMLINE PHOTOCOAGULATOR |
Applicant |
OPTIMEDICA CORPORATION |
155-A MOFFETT PARK DRIVE |
SUITE 210 |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
DARLENE CROCKETT-BILLING |
Correspondent |
OPTIMEDICA CORPORATION |
155-A MOFFETT PARK DRIVE |
SUITE 210 |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
DARLENE CROCKETT-BILLING |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 01/05/2010 |
Decision Date | 05/04/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|