CIRCUMAURAL ADHESIVE REPLACEMENT


Device Classification Name

stimulator, auditory, evoked response

510(k) Number K111555
Device Name CIRCUMAURAL ADHESIVE REPLACEMENT
Applicant
R & D MEDICAL PRODUCTS, INC.
20492 crescent bay dr. #106
lake forest, 
CA 
92630

Applicant Contact james perrault
Correspondent
R & D MEDICAL PRODUCTS, INC.
20492 crescent bay dr. #106
lake forest, 
CA 
92630

Correspodent Contact james perrault
Regulation Number 882.1900
Classification Product Code
GWJ  
Date Received 06/03/2011
Decision Date 07/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No