HEELBO WRAP AROUND VEST

Restraint, Protective

HEELBO, INC.

The following data is part of a premarket notification filed by Heelbo, Inc. with the FDA for Heelbo Wrap Around Vest.

Pre-market Notification Details

Device IDK963294
510k NumberK963294
Device Name:HEELBO WRAP AROUND VEST
ClassificationRestraint, Protective
Applicant HEELBO, INC. 2000 HOLLISTER DR. Libertyville,  IL  60048
ContactJoseph S Tokarz
CorrespondentJoseph S Tokarz
HEELBO, INC. 2000 HOLLISTER DR. Libertyville,  IL  60048
Product CodeFMQ  
CFR Regulation Number880.6760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-21
Decision Date1996-10-11
Summary:summary

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