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K Number
K954939
Device Name
MEDPOR OCULAR SCREW & ACCESSORIES
Manufacturer
POREX SURGICAL, INC.
Date Cleared
1996-01-25

(87 days)

Product Code
HPZ
Regulation Number
886.3320
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 886.3320 Eye sphere implant.

(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.