DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K072789
Device Name DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES
Applicant
ENCISION, INC.
6797 winchester cir.
boulder, 
CO 
80301

Applicant Contact judith v king
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 10/01/2007
Decision Date 10/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No