GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM

System, Test, Blood Glucose, Over The Counter

HMD BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Hmd Biomedical, Inc. with the FDA for Glucoleader Enhance Self-monitoring Of Blood Glucose System.

Pre-market Notification Details

Device IDK032985
510k NumberK032985
Device Name:GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant HMD BIOMEDICAL, INC. 3505 SUNSET AVE. Ocean,  NJ  07712
ContactJeffrey Fleishman
CorrespondentJeffrey Fleishman
HMD BIOMEDICAL, INC. 3505 SUNSET AVE. Ocean,  NJ  07712
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-24
Decision Date2003-10-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04711200722864 K032985 000
04711200721898 K032985 000
04711200720068 K032985 000
04711200720570 K032985 000
04711200721249 K032985 000
04711200721744 K032985 000
04711200720334 K032985 000
04711200722840 K032985 000
04711200720617 K032985 000
04711200721843 K032985 000

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