FDA.reportPublic FDA data

510(k) K924541

Device
EPIDURAL MINIPACK
Applicant
CONCORD/PORTEX
510(k) number
K924541
Product code
BYO  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1993-07-09
Date received
1992-09-08
Regulation
868.5220
Classification name
Bottle, Blow
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERT WHEELER
Address
15 Kitt St. Keene NH US 03431 03431

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BYO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K913527HYPERFREEKist Intl.1992-01-21
K780558BOTTLE BREATHING DEVICEB & F Medical Products, Inc.1978-05-26
K7804072C7125 BLOW BOTTLETravenol Laboratories, S.A.1978-04-10

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