FDA.reportPublic FDA data

510(k) K862412

Device
INTESTOPLANT
Applicant
BURRON MEDICAL PRODUCTS, INC.
510(k) number
K862412
Product code
LLD  
Decision
Substantially Equivalent (SESE)
Decision date
1986-11-13
Date received
1986-06-25
Regulation
510(k) Premarket Notification
Classification name
Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TRACEY YAKABOW
Address
824 Twelfth Ave. Bethlehem PA US 18018 18018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LLD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880072PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEMPharmacia Deltec, Inc.1988-03-29
K864552PORT-A-CATH IMPLANTABLE CATHETER SYSTEMPharmacia, Inc.1987-03-31
K832906PORT-A-CATH IMPLANTABLE CATHETER SYSPharmacia, Inc.1984-03-06

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases