EYE PROCEDURE PACK

Sponge, Ophthalmic

MARWOOD MEDICAL, INC.

The following data is part of a premarket notification filed by Marwood Medical, Inc. with the FDA for Eye Procedure Pack.

Pre-market Notification Details

Device IDK850340
510k NumberK850340
Device Name:EYE PROCEDURE PACK
ClassificationSponge, Ophthalmic
Applicant MARWOOD MEDICAL, INC. BOX 8712 Greensboro,  NC  27410
ContactDenise Ranck
CorrespondentDenise Ranck
MARWOOD MEDICAL, INC. BOX 8712 Greensboro,  NC  27410
Product CodeHOZ  
CFR Regulation Number886.4790 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-28
Decision Date1985-05-22

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