Device Classification Name |
Unit, Cautery, Thermal, Ac-Powered
|
510(k) Number |
K000893 |
Device Name |
AC POWERED THERMAL CAUTERY UNIT |
Applicant |
STARION INSTRUMENTS |
20665 4TH ST. |
SARATOGA,
CA
95070
|
|
Applicant Contact |
BRIAN GRIGSBY |
Correspondent |
STARION INSTRUMENTS |
20665 4TH ST. |
SARATOGA,
CA
95070
|
|
Correspondent Contact |
BRIAN GRIGSBY |
Regulation Number | 886.4115
|
Classification Product Code |
|
Date Received | 03/20/2000 |
Decision Date | 06/14/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|