Device Classification Name |
Unit, Cautery, Thermal, Ac-Powered
|
510(k) Number |
K070871 |
Device Name |
STARION UNIVERSAL POWER SUPPLY |
Applicant |
STARION INSTRUMENTS |
775 PALOMAR AVENUE |
SUNNYVALE,
CA
94085
|
|
Applicant Contact |
BRIAN GRIGSBY |
Correspondent |
STARION INSTRUMENTS |
775 PALOMAR AVENUE |
SUNNYVALE,
CA
94085
|
|
Correspondent Contact |
BRIAN GRIGSBY |
Regulation Number | 886.4115
|
Classification Product Code |
|
Date Received | 03/29/2007 |
Decision Date | 04/13/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|