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 K902783
Device Name PS MEDICAL DELTA CSF-FLOW CONTROL VALVE
Applicant
Pudenz-Schulte Medical Research Corp.
P.O. Box 2090
Goleta,  CA  93118
Applicant Contact STEPHEN LAGUETTE
Correspondent
Pudenz-Schulte Medical Research Corp.
P.O. Box 2090
Goleta,  CA  93118
Correspondent Contact STEPHEN LAGUETTE
Regulation Number882.5550
Classification Product Code
JXG  
Date Received06/26/1990
Decision Date 08/08/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-