PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K073057
Device Name PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040
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

Correspodent Contact grace carlson
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 10/30/2007
Decision Date 07/22/2008
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