Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K053433 |
Device Name |
CAUTERY TIP CLEANER, MODEL 30500 |
Applicant |
XODUS MEDICAL, INC. |
702 PROMINENCE DR. |
NEW KENSINGTON,
PA
15068
|
|
Applicant Contact |
BRENDA NIEL |
Correspondent |
XODUS MEDICAL, INC. |
702 PROMINENCE DR. |
NEW KENSINGTON,
PA
15068
|
|
Correspondent Contact |
BRENDA NIEL |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 12/09/2005 |
Decision Date | 01/19/2006 |
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
|