• 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 K013700
Device Name ORTHOSIS HELMET MOLDING
Applicant
PRECISION PROSTHETICS & ORTHOTICS, INC.
5353 WAYZATA BLVD. STE 505
MINNEAPOLIS,  MN  55416 -1334
Applicant Contact CONNIE FICKLIN
Correspondent
PRECISION PROSTHETICS & ORTHOTICS, INC.
5353 WAYZATA BLVD. STE 505
MINNEAPOLIS,  MN  55416 -1334
Correspondent Contact CONNIE FICKLIN
Regulation Number882.5970
Classification Product Code
MVA  
Date Received11/08/2001
Decision Date 02/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-