IONTOPHORESIS SYSTEM


Device Classification Name

device, iontophoresis, other uses

510(k) Number K073276
Device Name IONTOPHORESIS SYSTEM
Applicant
ACCLARENT, INC.
1525-b o’brien dr.
menlo park, 
CA 
94025

Applicant Contact keri yen
Correspondent
ACCLARENT, INC.
1525-b o’brien dr.
menlo park, 
CA 
94025

Correspodent Contact keri yen
Regulation Number 890.5525
Classification Product Code
EGJ  
Date Received 11/21/2007
Decision Date 03/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No