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 K012830
Device Name LERMAN & SON CRANIAL ORTHOSIS HELMET
Applicant
LERMAN & SON
8710 WILSHIRE BLVD.
BEVERLY HILLS,  CA  90211
Applicant Contact MAX LERMAN
Correspondent
LERMAN & SON
8710 WILSHIRE BLVD.
BEVERLY HILLS,  CA  90211
Correspondent Contact MAX LERMAN
Regulation Number882.5970
Classification Product Code
MVA  
Date Received08/23/2001
Decision Date 11/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-