FDA.reportPublic FDA data

510(k) K961993

Device
BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)
Applicant
DEVON INDUSTRIES, INC.
510(k) number
K961993
Product code
MLS  
Decision
Substantially Equivalent (SESE)
Decision date
1996-07-03
Date received
1996-05-21
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
GEORGE AUSTRIA
Address
9530 De Soto Ave. Chatsworth CA US 91311 91311

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
K960243CPR C-SECTION DELIVERY PACKCustom Pack Reliability1996-05-23
K940518C-SECTION TRAYCush Medical Products1994-08-18
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