Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K031085 |
Device Name |
GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) |
Applicant |
GYRUS MEDICAL, INC. |
6655 WEDGWOOD RD. |
SUITE 105 |
MAPLE GROVE,
MN
55311 -3602
|
|
Applicant Contact |
MERCEDES BAYANI |
Correspondent |
GYRUS MEDICAL, INC. |
6655 WEDGWOOD RD. |
SUITE 105 |
MAPLE GROVE,
MN
55311 -3602
|
|
Correspondent Contact |
MERCEDES BAYANI |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/04/2003 |
Decision Date | 07/21/2003 |
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
|