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510(k) Data Aggregation
K Number
K970320Device Name
SCLERAL SHELL
Manufacturer
XAVIER A. GUERRA, OCULARIST, INC.
Date Cleared
1997-07-07
(160 days)
Product Code
HQT
Regulation Number
886.3800Why did this record match?
Product Code :
HQT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Custom Scleral Cover Shell, is an ocular prosthesis, (artificial eye), fitted over a deformed, or disfigured blind eye, or over an eviscerated globe, for a specific patient. Scleral Cover Shells are also indicated for patients with Microphthalmia, Phthisis Bulbi, or other types of eye deformities.
In cases of infants and children with microphthalmia, and /or anophthalmia, the orbital fascia, bony orbit, and palpebral fissures, will be provided with the volume and surface area necessary to develop more normally, thus avoiding the complication of future deformities and possible corrective surgery.
Device Description
SCLERAL SHELL, an ocular prosthesis, (artificial eye)
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K Number
K970327Device Name
SCLERAL SHELL
Manufacturer
SOUTHWEST ARTIFICIAL EYES, INC.
Date Cleared
1997-07-07
(160 days)
Product Code
HQT
Regulation Number
886.3800Why did this record match?
Product Code :
HQT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Custom Scleral Cover Shell, is an ocular prosthesis, (artificial eye), fitted over a deformed, or disfigured blind eye, or over an eviscerated globe, for a specific patient. Scleral Cover Shells are also indicated for patients with Microphthalmia, Phthisis Bulbi, or other types of eye deformities.
In cases of infants and children with microphthalmia, and /or anophthalmia, the orbital fascia, bony orbit, and palpebral fissures, will be provided with the volume and surface area necessary to develop more normally, thus avoiding the complication of future deformities and possible corrective surgery.
Device Description
Not Found
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