Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K020585 |
Device Name |
ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT |
Applicant |
GYRUS MEDICAL, INC. |
6655 WEDGWOOD RD. |
MINNEAPOLIS,
MN
55311 -3602
|
|
Applicant Contact |
FREDERICK G MADES |
Correspondent |
GYRUS MEDICAL, INC. |
6655 WEDGWOOD RD. |
MINNEAPOLIS,
MN
55311 -3602
|
|
Correspondent Contact |
FREDERICK G MADES |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 02/22/2002 |
Decision Date | 07/13/2002 |
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
|