FDA.report

510(k) K896087

Device
PALESTRANT IRRIGATION AND DRAINAGE SET
Applicant
NORTH AMERICAN INSTRUMENT CORP.
510(k) number
K896087
Product code
KGZ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-11-03
Date received
1989-10-19
Regulation
878.4200
Classification name
Accessories, Catheter
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ROBERT E FRANKLIN
Address
Glens Falls NY US 12801 12801

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
20193489068242NAMICMEDLINE INDUSTRIES, INC.2023-12-21
H965905000501NAMICNAVILYST MEDICAL, INC.2016-09-20

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