ENVISAN PAD

Beads, Hydrophilic, For Wound Exudate Absorption

MARION LABORATORIES, INC.

The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Envisan Pad.

Pre-market Notification Details

Device IDK874552
510k NumberK874552
Device Name:ENVISAN PAD
ClassificationBeads, Hydrophilic, For Wound Exudate Absorption
Applicant MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City,  MI  64134
ContactWilliam H Guinty
CorrespondentWilliam H Guinty
MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City,  MI  64134
Product CodeKOZ  
CFR Regulation Number878.4018 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-04
Decision Date1988-01-22

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