HEADBAND FOR BAHA


the company

Device Classification Name

hearing aid, bone conduction

510(k) Number K002913
Device Name HEADBAND FOR BAHA
Original Applicant
ENTIFIC MEDICAL SYSTEMS, INC.
6470 riverview terrace
minneapolis, 
MN 
55432

Original Contact constance g bundy
Regulation Number 874.3300
Classification Product Code
LXB  
Date Received 09/18/2000
Decision Date 10/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

Type Traditional
Reviewed by Third Party No

Combination Product

No