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510(k) K914311

Device
CHIROFLEX II LENS MICROSERT(TM)
Applicant
CHIRON OPHTHALMICS
510(k) number
K914311
Product code
HQL  
Decision
Substantially Equivalent (SESE)
Decision date
1992-01-27
Date received
1991-09-26
Regulation
886.3600
Classification name
Intraocular Lens
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
3
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CAROL L PATTERSON
Address
9342 Jeronimo Rd. Irvine CA US 92718 92718

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HQL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K913626SOFTRANS INJECTORStaar Surgical Co.1991-12-18
K842892NIDEK DIGITAL KERATOMETERNidek, Inc.1984-10-05
K842504AMER. MEDICAL OPTICS DIGITAL KERATO-American Medical Optics1984-10-01
K771933CILCO ANTERIOR CHAMBER LENSCalifornia Intraocular Lens1978-01-26

Legacy Summary#

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FDA Review#

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