MEDI GUARD PILLOWCASE

Bedding, Disposable, Medical

SANCELLA, INC.

The following data is part of a premarket notification filed by Sancella, Inc. with the FDA for Medi Guard Pillowcase.

Pre-market Notification Details

Device IDK911948
510k NumberK911948
Device Name:MEDI GUARD PILLOWCASE
ClassificationBedding, Disposable, Medical
Applicant SANCELLA, INC. 6-2300 BRISTOL CIRCLE OAKVILLE, ONTARIO L6H 5S2 Canada,  CA
ContactDoreen Edey
CorrespondentDoreen Edey
SANCELLA, INC. 6-2300 BRISTOL CIRCLE OAKVILLE, ONTARIO L6H 5S2 Canada,  CA
Product CodeKME  
CFR Regulation Number880.6060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-01
Decision Date1991-05-28

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