Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K062257 |
Device Name |
STARION INSTRUMENTS THERMAL LITIGATING SHEARS |
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 | 878.4400
|
Classification Product Code |
|
Date Received | 08/04/2006 |
Decision Date | 10/10/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|