Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K003587 |
Device Name |
CLEARGLIDE PRECISION BIPOLAR DEVICE |
Applicant |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Applicant Contact |
GREGORY R JONES |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
ROBERT MOSENKIS |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 11/21/2000 |
Decision Date | 12/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|