FDA.reportPublic FDA data

510(k) K924277

Device
DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING
Applicant
CHALGREN ENTERPRISES, INC.
510(k) number
K924277
Product code
HLT  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-07
Date received
1992-08-25
Regulation
886.1640
Classification name
Preamplifier, Ac-powered, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICHARD KAISER
Address
8021 Carmel St. Suite B Gilroy CA US 95020 95020

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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