Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K110924 |
Device Name |
DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS |
Applicant |
SYNERGETICS, INC |
3845 CORPORATE CENTRE DRIVE |
O'FALLON,
MO
63368
|
|
Applicant Contact |
GARY OLIVEROS |
Correspondent |
SYNERGETICS, INC |
3845 CORPORATE CENTRE DRIVE |
O'FALLON,
MO
63368
|
|
Correspondent Contact |
GARY OLIVEROS |
Regulation Number | 878.4400 |
Classification Product Code |
|
Date Received | 04/04/2011 |
Decision Date | 12/07/2011 |
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
|
Predetermined Change Control Plan Authorized |
No
|
Recalls |
CDRH Recalls
|