OCU-GUARD AND OCU-GUARD SUPPLE

Implant, Orbital, Extra-ocular

BIO-VASCULAR, INC.

The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Ocu-guard And Ocu-guard Supple.

Pre-market Notification Details

Device IDK983581
510k NumberK983581
Device Name:OCU-GUARD AND OCU-GUARD SUPPLE
ClassificationImplant, Orbital, Extra-ocular
Applicant BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
ContactDianna L Geck
CorrespondentDianna L Geck
BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
Product CodeHQX  
CFR Regulation Number886.3340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-13
Decision Date1998-11-06
Summary:summary

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