Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Orthosis, Cranial
510(k) Number K023572
Device Name LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
Applicant
REHABILITATION INSTITUTE,LOMA LINDA UNIVERSITY MED
BANK ONE PLAZA, 10 S. DEARBORN
CHICAGO,  IL  60603
Applicant Contact LYNN D FLEISHER
Correspondent
REHABILITATION INSTITUTE,LOMA LINDA UNIVERSITY MED
BANK ONE PLAZA, 10 S. DEARBORN
CHICAGO,  IL  60603
Correspondent Contact LYNN D FLEISHER
Regulation Number882.5970
Classification Product Code
MVA  
Date Received10/24/2002
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
-
-