FDA.reportPublic FDA data

510(k) K841007

Device
OPHTHALMIC CURETTE-VARIOUS
Applicant
PREMIER DENTAL PRODUCTS CO.
510(k) number
K841007
Product code
HNZ  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-09
Date received
1984-03-09
Regulation
886.4350
Classification name
Curette, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K870437LOOK CAPSULE POLISHERS/SCRAPERSLook, Inc.1987-02-20

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