Device Classification Name |
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
|
510(k) Number |
K142525 |
Device Name |
PK Lap Loop |
Applicant |
Olympus Winter & Ibe GmbH |
Kuehnstrasse 61 |
Hamburg,
DE
22045
|
|
Applicant Contact |
Graham A.L. Baillie |
Correspondent |
Olympus Surgical Tech America, Gyrus ACMI, Inc. |
136 Turnpike Road |
Southborough,
MA
01772
|
|
Correspondent Contact |
Graham A.L. Baillie |
Regulation Number | 884.4150
|
Classification Product Code |
|
Date Received | 09/08/2014 |
Decision Date | 11/21/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|