Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K092309 |
Device Name |
SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034
|
|
Applicant Contact |
STACY ABBATIELLO KLUESNER |
Correspondent |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034
|
|
Correspondent Contact |
STACY ABBATIELLO KLUESNER |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 07/30/2009 |
Decision Date | 10/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|