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
510(k) Number K864754
Device Name BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR
Applicant
Pudenz-Schulte Medical Research Corp.
P.O. Box 2090
Goleta,  CA  93118
Applicant Contact STEPHEN W LAGUETTE
Correspondent
Pudenz-Schulte Medical Research Corp.
P.O. Box 2090
Goleta,  CA  93118
Correspondent Contact STEPHEN W LAGUETTE
Date Received12/05/1986
Decision Date 12/22/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-