FDA.reportPublic FDA data

510(k) K871195

Device
MALLET, BONE SURGERY, STAINLESS STEEL, 2LB.
Applicant
MILITARY ENGINEERING, INC.
510(k) number
K871195
Product code
HXL  
Decision
Substantially Equivalent (SESE)
Decision date
1987-04-06
Date received
1987-03-24
Regulation
878.4800
Classification name
Mallet
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEE L HEYDE
Address
P.O. Box J 2135 Western Ave. Plymouth IN US 46563 46563

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HXL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K882349MALLET, SURGICALTreace Medical, Inc.1988-06-23
K872209ARTHROPLASTY MALLETNew England Surgical Instrument Corp.1987-06-23

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