Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K080187 |
Device Name |
OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS |
Applicant |
OLSEN MEDICAL |
3001 WEST KENTUCKY ST. |
LOUISVILLE,
KY
40211
|
|
Applicant Contact |
JOHN P WATERS |
Correspondent |
OLSEN MEDICAL |
3001 WEST KENTUCKY ST. |
LOUISVILLE,
KY
40211
|
|
Correspondent Contact |
JOHN P WATERS |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 01/25/2008 |
Decision Date | 05/09/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|