KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)

Dressing, Wound, Drug

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 Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317).

Pre-market Notification Details

Device IDK973507
510k NumberK973507
Device Name:KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
ClassificationDressing, Wound, Drug
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 CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-16
Decision Date1997-12-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884527014955 K973507 000
10884527014927 K973507 000
50749756028986 K973507 000

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