FDA.reportPublic FDA data

510(k) K022723

Device
MASTEL 1 FOLDER IMPLANTATION SYSTEM
Applicant
Mastel Precision, Inc.
510(k) number
K022723
Product code
KYB
Decision
Substantially Equivalent (SESE)
Decision date
2002-12-26
Date received
2002-08-16
Regulation
886.4300
Classification name
Lens, Guide, Intraocular
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
MAUREEN WEINER
Address
53 Barcelona Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KYB#

510(k), Device, Applicant table
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K072985DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2Duckworth & Kent, Ltd.2008-06-20
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K032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SStaar Surgical Co.2004-06-10
K001157MONARCH II IOL DELIVERY SYSTEMAlcon Research, Ltd.2000-06-27
K983129DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)Staar Surgical Co.1998-12-04
K981571MONARCH IOL DELIVERY SYSTEMAlcon Laboratories1998-07-09
K970033MONARCH IOL DELIVERY SYSTEMAlcon Laboratories1997-04-23
K965185ACRYPAK FOLDERAlcon Laboratories1997-03-31
K961242AMO PHACOFLEX II INTERSECTION SYSTEMAllergan, Inc.1996-06-17
K954600MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)Staar Surgical Co.1995-12-21
K951292PASSPORT FOLDABLE LENS PLACEMENT SYSTEMChiron Vision Corp.1995-06-02