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510(k) K863775

Device
RK VACUUM FIXATION RING SYSTEM
Applicant
AMERITEK, INC.
510(k) number
K863775
Product code
HNH  
Decision
Substantially Equivalent (SESE)
Decision date
1986-10-20
Date received
1986-09-26
Regulation
886.4350
Classification name
Ring, Ophthalmic (flieringa)
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT GALAN
Address
7030 35th Ave., NE Seattle WA US 98115 98115

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K912268LANDERS NOTCHED VITRECTOMY LENS RINGOcular Instruments, Inc.1991-08-07
K912269LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RINGOcular Instruments, Inc.1991-08-07
K912151LANDERS THREE STRUT VITRECTOMY LENS RINGOcular Instruments, Inc.1991-07-25
K902496LANDERS VITRECTOMY LENS RING W/INFUSIONOcular Instruments, Inc.1990-07-24
K850991LANDERS VITRECTOMY LENS RING SYSTEMSOcular Instruments, Inc.1985-03-29
K832912GELENDER VACUUM FIXATION RING SYSMiami Eye Technology, Inc.1984-01-10

Legacy Summary#

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FDA Review#

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