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 drills, burrs, trephines & accessories (manual)
510(k) Number K915546
Device Name PS MEDICAL VENTRICULOSTOMY KIT
Applicant
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
P.O. BOX 2090
GOLETA,  CA  93118
Applicant Contact TOM HOLDYCH
Correspondent
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
P.O. BOX 2090
GOLETA,  CA  93118
Correspondent Contact TOM HOLDYCH
Regulation Number882.4300
Classification Product Code
HBG  
Date Received12/11/1991
Decision Date 12/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-