OTICON /PRIMOFOCUS (PF)


Device Classification Name

hearing aid, air conduction

510(k) Number K960284
Device Name OTICON /PRIMOFOCUS (PF)
Applicant
OTICON, INC.
29 schoolhouse rd.
somerset, 
NJ 
08873

Applicant Contact preben brunved
Correspondent
OTICON, INC.
29 schoolhouse rd.
somerset, 
NJ 
08873

Correspodent Contact preben brunved
Regulation Number 874.3300
Classification Product Code
ESD  
Date Received 01/19/1996
Decision Date 03/07/1996
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

Category: Uncategorized