MI DeTACH

Clamp, Vascular

Biorep Technologies, Inc

The following data is part of a premarket notification filed by Biorep Technologies, Inc with the FDA for Mi Detach.

Pre-market Notification Details

Device IDK210006
510k NumberK210006
Device Name:MI DeTACH
ClassificationClamp, Vascular
Applicant Biorep Technologies, Inc 15804 NW 57th Avenue Miami Lakes,  FL  33014
ContactVictoria Enjamio
CorrespondentVictoria Enjamio
Biorep Technologies, Inc 15804 NW 57th Avenue Miami Lakes,  FL  33014
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-04
Decision Date2021-03-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858733006338 K210006 000
00858733006291 K210006 000
00858733006284 K210006 000
00858733006307 K210006 000
00858733006246 K210006 000

Trademark Results [MI DeTACH]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MI DETACH
MI DETACH
86663016 5628163 Live/Registered
Miami Instruments LLC
2015-06-15

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