FDA.reportPublic FDA data

510(k) K940518

Device
C-SECTION TRAY
Applicant
CUSH MEDICAL PRODUCTS
510(k) number
K940518
Product code
MLS  
Decision
Substantially Equivalent - Kit With Drugs (SEKD)
Decision date
1994-08-18
Date received
1994-02-04
Regulation
884.4530
Classification name
Labor And Delivery Kit
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STEVE B JOHNSTON
Address
P.O. Box 247 881 Mountain View Dr. Piney Flats TN US 37686 37686

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MLS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961993BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)Devon Industries, Inc.1996-07-03
K960243CPR C-SECTION DELIVERY PACKCustom Pack Reliability1996-05-23
K932216C-SECTION, LABOR & DELIVERY TRAYS (PACKS)Associated Medical Products Co.1994-04-19
K936120LABOR AND DELIVERY TRAYCush Medical Products1994-03-30
K931722CARAPACE LABOR AND DELIVERY SETSCarapace, Inc.1994-03-23

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