FDA.reportPublic FDA data

510(k) K901426

Device
COLONIC BALLOON DILATOR
Applicant
TELEMED SYSTEMS, INC.
510(k) number
K901426
Product code
FFP  
Decision
Substantially Equivalent (SESE)
Decision date
1990-06-21
Date received
1990-03-26
Regulation
876.5450
Classification name
Dilator, Rectal
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN A CHAVES
Address
8 Kane Industrial Dr. Hudson MA US 01749 01749

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FFP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K964634ANOKRYOMk Conquest Intl., Inc.1997-06-06
K894618INAMED RHEMO-D (TM) DILATORInamed Development Co.1990-01-18
K884713COLONIC BALLOON DIALATORSPrimrose Medical, Inc.1989-09-29
K830354COLORECTAL DILATORCleveland Medical Supply & Services1983-05-27

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