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510(k) K984537

Device
KERATOME SYSTEM, MODEL K3000
Applicant
INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.
510(k) number
K984537
Product code
HMY  
Decision
Substantially Equivalent (SESE)
Decision date
1999-05-14
Date received
1998-12-21
Regulation
886.4370
Classification name
Keratome, Battery-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CHARLES VASSALLO
Address
264 Quarry Rd. Milford CT US 06460 06460

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HMY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040297ONEUSE- PLUS MICROKERATOMEMoria SA2004-03-31
K023092BD K-4000 MICROKERATOME SYSTEMBecton, Dickinson & CO2002-10-18
K022637BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOMEBecton, Dickinson & CO2002-10-16
K022560M2 SINGLE USE MICROKERTOMEMoria SA2002-09-27
K003594CARRIAZO BARRAQUER SINGLE USE MICROKERATOMEMoria, Inc.2001-03-09
K002191CARRIAZO BARRAQUER II MICROKERATOMEMoria, Inc.2000-10-12
K992687MILLENIUM MICROKERATOME, MODEL IMD-001Industrial & Medical Design, Inc.1999-09-24
K981741CARRIAZO BARRAQUER MICROKERATOMEMoria, Inc.1998-07-24
K974243KERATOME SYSTEMInsight Technologies Instruments, LLC1998-01-20
K902857VISI-DRAPE OPHTHALMIC DRAPESVisitec Co.1990-07-31
K781412OSCILLATING KNIFE AND ACCESSORIESCodman & Shurtleff, Inc.1978-10-11

Legacy Summary#

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FDA Review#

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