DENSTAT


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K010465
Device Name DENSTAT
Original Applicant
ELMED, INC.
60 west fay ave.
addison, 
IL 
60101

Original Contact werner hausner
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 02/16/2001
Decision Date 05/14/2001
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