P-NAIN SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K072833
Device Name P-NAIN SYSTEM
Applicant
JEISYS MEDICAL, INC.
13 red fox lane
littleton, 
CO 
80127

Applicant Contact kevin walls
Correspondent
JEISYS MEDICAL, INC.
13 red fox lane
littleton, 
CO 
80127

Correspodent Contact kevin walls
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 10/03/2007
Decision Date 01/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No