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 shunt, central nervous system and components
510(k) Number K013488
Device Name SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
Applicant
SOPHYSA SA
70 WALNUT ST.
WELLESLEY,  MA  02481
Applicant Contact JACQUELINE E MASSE
Correspondent
SOPHYSA SA
70 WALNUT ST.
WELLESLEY,  MA  02481
Correspondent Contact JACQUELINE E MASSE
Regulation Number882.5550
Classification Product Code
JXG  
Date Received10/19/2001
Decision Date 03/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-