CURASALT HYPERTONIC SALINE DRESSING

Bandage, Liquid

KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH

The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Curasalt Hypertonic Saline Dressing.

Pre-market Notification Details

Device IDK942459
510k NumberK942459
Device Name:CURASALT HYPERTONIC SALINE DRESSING
ClassificationBandage, Liquid
Applicant KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield,  MA  02048
ContactDavid A Olson
CorrespondentDavid A Olson
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield,  MA  02048
Product CodeKMF  
CFR Regulation Number880.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-24
Decision Date1994-06-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884527016669 K942459 000

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