DRESSING CHANGE KIT

Mask, Surgical

HEALTHDYNE CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Healthdyne Cardiovascular, Inc. with the FDA for Dressing Change Kit.

Pre-market Notification Details

Device IDK900665
510k NumberK900665
Device Name:DRESSING CHANGE KIT
ClassificationMask, Surgical
Applicant HEALTHDYNE CARDIOVASCULAR, INC. 45 PARKER ST., SUITE A Irvine,  CA  92618 -1658
ContactBill Welch
CorrespondentBill Welch
HEALTHDYNE CARDIOVASCULAR, INC. 45 PARKER ST., SUITE A Irvine,  CA  92618 -1658
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-13
Decision Date1990-05-14

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