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 K961859
Device Name NOVUS STANDARD AND PEDIATRIC VALVES
Applicant
INTEGRA NEUROCARE LLC.
8401 102ND ST.
SUITE 200-P.O. BOX 390
PLEASANT PRAIRIE,  WI  53150 -0390
Applicant Contact TERRY N LAYTON
Correspondent
INTEGRA NEUROCARE LLC.
8401 102ND ST.
SUITE 200-P.O. BOX 390
PLEASANT PRAIRIE,  WI  53150 -0390
Correspondent Contact TERRY N LAYTON
Regulation Number882.5550
Classification Product Code
JXG  
Date Received05/14/1996
Decision Date 12/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-