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 Catheter, Percutaneous, Intraspinal, Short Term
510(k) Number K911382
Device Name IPI ALGO-LINE CATHETER
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 Number868.5120
Classification Product Code
MAJ  
Date Received03/28/1991
Decision Date 07/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-