FDA.reportPublic FDA data

510(k) K931792

Device
ARTHROSCOPE
Applicant
INTRAMED LABORATORIES, INC.
510(k) number
K931792
Product code
HRH  
Decision
Substantially Equivalent (SESE)
Decision date
1994-06-13
Date received
1993-04-12
Regulation
886.4350
Classification name
Trephine, Manual, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
STEPHEN SOSNOWSKI
Address
11100 Roselle St. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HRH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022843GAYHEART CORNEAL EXCISION DEVICEStephens Instruments2002-11-01
K873918HEAD & CHIN RESTSRichmond Products, Inc.1987-10-28
K864520BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRONPrecision Instruments, Inc.1987-01-20
K862524DEKNATEL (R) TREPHINEDeknatel, Inc.1986-08-11
K861825CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADEStorz Instrument Co.1986-06-09
K860648BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIAPrecision Instruments, Inc.1986-03-25
K843646STEINWAY MICRO-KERATO-TREPHINESteinway Instrument Co., Inc.1985-01-03
K843048RING SUPPORTED TREPHINE FOR CORNEA TRANSPrecision Instruments, Inc.1984-10-05
K812723PEARCE CORNEAL TREPHINEVisitec Co.1981-10-13
K781411CORNEAL CUTTER AND ACCESSORIESCodman & Shurtleff, Inc.1978-09-20
K771866TROUTMAN CORNEAL PUNCHEdward Weck, Inc.1977-11-09

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