Device Classification Name |
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
|
510(k) Number |
K122605 |
Device Name |
PKS BILL |
Applicant |
GYRUS ACMI, INC. |
136 TURNPIKE RD. |
SOUTHBOROUGH,
MA
01772
|
|
Applicant Contact |
NEIL KELLY |
Correspondent |
GYRUS ACMI, INC. |
136 TURNPIKE RD. |
SOUTHBOROUGH,
MA
01772
|
|
Correspondent Contact |
NEIL KELLY |
Regulation Number | 884.4150
|
Classification Product Code |
|
Date Received | 08/27/2012 |
Decision Date | 12/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|