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510(k) K913626

Device
SOFTRANS INJECTOR
Applicant
STAAR SURGICAL CO.
510(k) number
K913626
Product code
HQL  
Decision
Substantially Equivalent (SESE)
Decision date
1991-12-18
Date received
1991-08-15
Regulation
886.3600
Classification name
Intraocular Lens
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
3
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID S FERNQUIST
Address
1911 Walker Ave. Monrovia CA US 91016 91016

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HQL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914311CHIROFLEX II LENS MICROSERT(TM)Chiron Ophthalmics1992-01-27
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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