Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K884656 |
Device Name |
DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEP |
Applicant |
DERMACARE |
7651 NATIONAL TURNPIKE |
LOUISVILLE,
KY
40214
|
|
Applicant Contact |
RYAN M SELL |
Correspondent |
DERMACARE |
7651 NATIONAL TURNPIKE |
LOUISVILLE,
KY
40214
|
|
Correspondent Contact |
RYAN M SELL |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 11/07/1988 |
Decision Date | 11/25/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|