GYRUS PLASMA SKIN RESURFACING SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K023111
Device Name GYRUS PLASMA SKIN RESURFACING SYSTEM
Original Applicant
GYRUS MEDICAL, INC.
6655 wedgwood rd.
suite 105
maple grove, 
MN 
55311 -3602

Original Contact mark jensen
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 09/19/2002
Decision Date 03/13/2003
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