MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR

Chair, Ophthalmic, Ac-powered

MARCO OPHTHALMIC, INC.

The following data is part of a premarket notification filed by Marco Ophthalmic, Inc. with the FDA for Marco, Marcotilt, Encore And Custom Chair.

Pre-market Notification Details

Device IDK930449
510k NumberK930449
Device Name:MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR
ClassificationChair, Ophthalmic, Ac-powered
Applicant MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY. Jacksonville,  FL  32224
ContactWayne Starling
CorrespondentWayne Starling
MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY. Jacksonville,  FL  32224
Product CodeHME  
CFR Regulation Number886.1140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-26
Decision Date1993-07-06

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