SPIVEY-ALLEN ORBITAL FLOOR IMPLANT

Implant, Orbital, Extra-ocular

OCULO PLASTIK, INC.

The following data is part of a premarket notification filed by Oculo Plastik, Inc. with the FDA for Spivey-allen Orbital Floor Implant.

Pre-market Notification Details

Device IDK900930
510k NumberK900930
Device Name:SPIVEY-ALLEN ORBITAL FLOOR IMPLANT
ClassificationImplant, Orbital, Extra-ocular
Applicant OCULO PLASTIK, INC. 1170 EAST HENRI-BOURASSA BLVD. Montreal, Quebec Canada,  CA H2c 1g4
ContactJean-francois Durett
CorrespondentJean-francois Durett
OCULO PLASTIK, INC. 1170 EAST HENRI-BOURASSA BLVD. Montreal, Quebec Canada,  CA H2c 1g4
Product CodeHQX  
CFR Regulation Number886.3340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-27
Decision Date1990-05-15

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