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510(k) K945172

Device
VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
Applicant
VISITEC CO.
510(k) number
K945172
Product code
HQX  
Decision
Substantially Equivalent (SESE)
Decision date
1995-01-17
Date received
1994-10-21
Regulation
886.3340
Classification name
Implant, Orbital, Extra-ocular
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID A CLAPP
Address
7575 Commerce Ct. Sarasota FL US 34243 34243

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HQX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023481MICROVISION SCLERAL BUCKLING COMPONENTSMicrovision, Inc.2003-01-08
K983581OCU-GUARD AND OCU-GUARD SUPPLEBio-Vascular, Inc.1998-11-06
K980816RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGESFci Ophthalmics, Inc.1998-09-18
K963219RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGESFci Ophthalmics, Inc.1996-10-28
K950806SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTSMira, Inc.1996-06-05
K950599STORS SCLERAL SPONGE II (LINCOFF DESIGN)Storz Ophthalmics, Inc.1995-03-02
K902308TAMCENAN OCULAR EXPLANTS AND BANDSTamcenan Corp.1990-06-19
K901002O'DONNELL, SOCKET RECONSTRUCTION PROSTHESESOculo Plastik, Inc.1990-05-22
K900929PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERALOculo Plastik, Inc.1990-05-18
K900927CODERE-DURETTE ORBITAL FLOOR IMPLANTOculo Plastik, Inc.1990-05-15
K900928COX MALAR EMINENCE IMPLANTSOculo Plastik, Inc.1990-05-15
K900930SPIVEY-ALLEN ORBITAL FLOOR IMPLANTOculo Plastik, Inc.1990-05-15
K863946POREX(TM) EXTRA-OCULAR ORBITAL IMPLANTPorex Medical1987-02-27
K832481SCLERAL BUCKLING IMPLANTS DIF/TYPESStorz Instrument Co.1983-09-20
K800140SILASTIC SCLERAL SPONGE II W/CIRCLING BDDow Corning Corp. Healthcare Industries Materials1980-03-03

Legacy Summary#

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FDA Review#

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