GREAT HANDS MITTS

Restraint, Protective

HEELBO, INC.

The following data is part of a premarket notification filed by Heelbo, Inc. with the FDA for Great Hands Mitts.

Pre-market Notification Details

Device IDK962810
510k NumberK962810
Device Name:GREAT HANDS MITTS
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 Received1996-07-18
Decision Date1996-10-09
Summary:summary

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