LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET


Device Classification Name

orthosis, cranial

510(k) Number K023572
Device Name LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
Original Applicant
REHABILITATION INSTITUTE,LOMA LINDA UNIVERSITY MED
bank one plaza, 10 s. dearborn
chicago, 
IL 
60603

Original Contact lynn d fleisher
Regulation Number 882.5970
Classification Product Code
MVA  
Date Received 10/24/2002
Decision Date 01/13/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No