FDA.reportPublic FDA data

510(k) K864770

Device
SUCTION TUBE
Applicant
NEW ENGLAND SURGICAL INSTRUMENT CORP.
510(k) number
K864770
Product code
FFA  
Decision
Substantially Equivalent (SESE)
Decision date
1987-02-24
Date received
1986-12-05
Regulation
876.5090
Classification name
Tube, Drainage, Suprapubic
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RICHARD M BEANE
Address
P.O. Box 35 83 E. Water St. Rockland MA US 02370 02370

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FFA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944290CATHETERS, BILIARY CATHETERS, UROLOGICALBoston Scientific Corp1994-12-08
K833061C-FLEX PENROSE DRAINAGE TUBEConcept, Inc.1983-11-07

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