FDA.reportPublic FDA data

510(k) K864470

Device
HEMOREST(TM)
Applicant
HEALTH AID PRODUCTS
510(k) number
K864470
Product code
LRL  
Decision
Substantially Equivalent (SESE)
Decision date
1987-06-23
Date received
1986-11-12
Regulation
510(k) Premarket Notification
Classification name
Cushion, Hemorrhoid
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
Gastroenterology/Urology
Device class
U
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAUL SALVER
Address
5881 NW 151st St. Suite 101a Miami Lakes FL US 33014 33014

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LRL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K072690HEMAWAY SEATHemaway, LLC2007-12-07
K932396PERI-COMFORT(TM) SEATING CUSHIONChi'Am Intl.1993-09-30

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