HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM


Device Classification Name

device, iontophoresis, other uses

510(k) Number K072946
Device Name HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
Applicant
EMPI
599 cardigan rd.
st. paul, 
MN 
55126

Applicant Contact sandra walrod
Correspondent
EMPI
599 cardigan rd.
st. paul, 
MN 
55126

Correspodent Contact sandra walrod
Regulation Number 890.5525
Classification Product Code
EGJ  
Date Received 10/17/2007
Decision Date 11/16/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

Type Special
Reviewed by Third Party No

Combination Product

No