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 K011433
Device Name BALLERT CRANIAL MOLDING HELMET
Applicant
Gema, Inc.
2434 W. Peterson Ave.
Chicago,  IL  60659
Applicant Contact GENE BERNARDONI
Correspondent
Gema, Inc.
2434 W. Peterson Ave.
Chicago,  IL  60659
Correspondent Contact GENE BERNARDONI
Regulation Number882.5970
Classification Product Code
MVA  
Date Received05/10/2001
Decision Date 06/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-