BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)


Device Classification Name

hearing aid, bone conduction

510(k) Number K021837
Device Name BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
Original Applicant
ENTIFIC MEDICAL SYSTEMS, INC.
6470 riverview terrace
minneapolis, 
MN 
55432

Original Contact constance bundy
Regulation Number 874.3300
Classification Product Code
LXB  
Date Received 06/04/2002
Decision Date 08/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No