FDA.reportPublic FDA data

510(k) K862070

Device
INTER-SHARP
Applicant
INTERMEDICS INTRAOCULAR, INC.
510(k) number
K862070
Product code
HNW  
Decision
Substantially Equivalent (SESE)
Decision date
1986-06-17
Date received
1986-05-30
Regulation
886.4350
Classification name
Dilator, Lachrymal
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ENID ROKAW
Address
2650 E. Foothill Blvd. P.O. Box 70670 Passadena CA US 91107 91107

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K841002LACHRYMAL PROBES-VARIOUSPremier Dental Products Co.1984-05-09
K812097KOI LACREMAL HOOK & DILATORKoi, Inc.1981-08-18

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