• 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 Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K934167
Device Name IPI DUAL LUMEN PORT
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 Number880.5965
Classification Product Code
LJT  
Date Received08/27/1993
Decision Date 07/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-