CRANIAL REMOLDING ORTHOSIS


Device Classification Name

orthosis, cranial

510(k) Number K111247
Device Name CRANIAL REMOLDING ORTHOSIS
Applicant
ORTHOTIC CARE SERVICES, LLP
360 sherman street, suite 299
st.paul, 
MN 
55102

Applicant Contact scott hinshon
Correspondent
ORTHOTIC CARE SERVICES, LLP
360 sherman street, suite 299
st.paul, 
MN 
55102

Correspodent Contact scott hinshon
Regulation Number 882.5970
Classification Product Code
MVA  
Date Received 05/03/2011
Decision Date 08/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No