Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K093695 |
Device Name |
PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE |
Applicant |
PEAK SURGICAL, INC. |
2464 EMBARCADERO WAY |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
LOIS NAKAYAMA |
Correspondent |
PEAK SURGICAL, INC. |
2464 EMBARCADERO WAY |
PALO ALTO,
CA
94303
|
|
Correspondent Contact |
LOIS NAKAYAMA |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 11/30/2009 |
Decision Date | 04/13/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|