Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K973478 |
Device Name |
ARTHROCARE SINUS ELECTROSURGERY SYSTEM |
Applicant |
ARTHROCARE CORP. |
595 NORTH PASTORIA AVE. |
SUNNYVALE,
CA
94085 -2936
|
|
Applicant Contact |
Mark Smutka |
Correspondent |
ARTHROCARE CORP. |
595 NORTH PASTORIA AVE. |
SUNNYVALE,
CA
94085 -2936
|
|
Correspondent Contact |
Mark Smutka |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/15/1997 |
Decision Date | 01/09/1998 |
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
|