Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K081580 |
Device Name |
BEAMER ARGON SNARE PROBE |
Applicant |
CONMED CORPORATION |
129 CONCORD RD. |
BLDG. #3 |
BILLERICA,
MA
01821
|
|
Applicant Contact |
KAREN PROVENCHER |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
KACHI ENYINNA |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/05/2008 |
Decision Date | 06/19/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|