PRIMAEVA MEDICAL SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K080145
Device Name PRIMAEVA MEDICAL SYSTEM
Applicant
PRIMAEVA MEDICAL, INC.
42840 christy street
suite 101
fremont, 
CA 
94538

Applicant Contact brian grigsby
Correspondent
PRIMAEVA MEDICAL, INC.
42840 christy street
suite 101
fremont, 
CA 
94538

Correspodent Contact brian grigsby
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 01/22/2008
Decision Date 02/28/2008
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