Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K082786 |
Device Name |
PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES |
Applicant |
PEAK SURGICAL, INC. |
2464 EMBARCADERO WAY |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
GRACE CARLSON |
Correspondent |
PEAK SURGICAL, INC. |
2464 EMBARCADERO WAY |
PALO ALTO,
CA
94303
|
|
Correspondent Contact |
GRACE CARLSON |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/23/2008 |
Decision Date | 12/03/2008 |
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
|
|
|