TULA IONTOPHORESIS SYSTEM


Device Classification Name

device, iontophoresis, other uses

510(k) Number K110636
Device Name TULA IONTOPHORESIS SYSTEM
Applicant
ACCLARENT, INC.
1525-b o’brien dr.
menlo park, 
CA 
94025

Applicant Contact gurvinder singh nanda
Correspondent
ACCLARENT, INC.
1525-b o’brien dr.
menlo park, 
CA 
94025

Correspodent Contact gurvinder singh nanda
Regulation Number 890.5525
Classification Product Code
EGJ  
Date Received 03/04/2011
Decision Date 06/16/2011
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