FDA.reportPublic FDA data

510(k) K861749

Device
3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE
Applicant
KEELER INSTRUMENTS, INC.
510(k) number
K861749
Product code
FSP  
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-23
Date received
1986-05-06
Regulation
878.4800
Classification name
Loupe, Diagnostic/surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
VAN ARSDALE
Address
456 Pkwy. Broomall PA US 19008 19008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FSP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K895248IMS5000 ILLUMINATED LOUPESLuxtec Corp.1989-09-15
K891895SURGICAL LOUPESZinnanti Surgical Instruments, Inc.1989-04-12
K864386LUXTEC LOUPES FOR SURGICAL VISIONLuxtec Corp.1986-11-17

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