PROVOX FREEHANDS HME, MODEL 7710


Device Classification Name

prosthesis, laryngeal (taub)

510(k) Number K022125
Device Name PROVOX FREEHANDS HME, MODEL 7710
Original Applicant
ATOS MEDICAL AB
kraftgatan 8
p.o.box 183
horby, 

SE

se-242 22

Original Contact eddy aberg
Regulation Number 874.3730
Classification Product Code
EWL  
Date Received 07/01/2002
Decision Date 07/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No