MEDPOR QUAD MOTILITY IMPLANT

Implant, Eye Sphere

POREX SURGICAL, INC.

The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Quad Motility Implant.

Pre-market Notification Details

Device IDK010902
510k NumberK010902
Device Name:MEDPOR QUAD MOTILITY IMPLANT
ClassificationImplant, Eye Sphere
Applicant POREX SURGICAL, INC. 15 DART RD. Newnan,  GA  30265
ContactHoward Mercer
CorrespondentHoward Mercer
POREX SURGICAL, INC. 15 DART RD. Newnan,  GA  30265
Product CodeHPZ  
CFR Regulation Number886.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-26
Decision Date2001-06-19

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