Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K083895 |
Device Name |
CODMAN ISOCOOL BIPOLAR FORCEPS |
Applicant |
Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Applicant Contact |
EMILY E VALERIO |
Correspondent |
Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Correspondent Contact |
EMILY E VALERIO |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 12/29/2008 |
Decision Date | 06/23/2009 |
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
|
Recalls |
CDRH Recalls
|