INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET

Pack, Hot Or Cold, Water Circulating

HOLLISTER, INC.

The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Incare Hot/ice System Foot/ankle Blanket.

Pre-market Notification Details

Device IDK973023
510k NumberK973023
Device Name:INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
ClassificationPack, Hot Or Cold, Water Circulating
Applicant HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville,  IL  60048
ContactJoseph S Tokarz
CorrespondentJoseph S Tokarz
HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville,  IL  60048
Product CodeILO  
CFR Regulation Number890.5720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-14
Decision Date1997-11-03
Summary:summary

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