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 K003630
Device Name DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
Applicant
DANMAR PRODUCTS, INC.
221 JACKSON INDUSTRIAL DR.
ANN ARBOR,  MI  48103
Applicant Contact KAREN A LINDNER
Correspondent
DANMAR PRODUCTS, INC.
221 JACKSON INDUSTRIAL DR.
ANN ARBOR,  MI  48103
Correspondent Contact KAREN A LINDNER
Regulation Number882.5970
Classification Product Code
MVA  
Date Received11/24/2000
Decision Date 05/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-