PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K103375
Device Name PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL
Applicant
MEDTEK DEVICES, INC.
595 commerce dr.
amherst, 
NY 
14228

Applicant Contact greg pepe
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 11/16/2010
Decision Date 03/16/2011
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