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 instrument, shunt system implantation
510(k) Number K930606
Device Name PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
Applicant
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
125-B CREMONA DR.
GOLETA,  CA  93117
Applicant Contact TOM HOLDYCH
Correspondent
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
125-B CREMONA DR.
GOLETA,  CA  93117
Correspondent Contact TOM HOLDYCH
Regulation Number882.4545
Classification Product Code
GYK  
Date Received02/05/1993
Decision Date 09/10/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-