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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K911948
Device Name MEDI GUARD PILLOWCASE
Applicant
Sancella, Inc.
6-2300 Bristol Cir.
Oakville, Ontario L6h 5s2
Canada,  CA
Applicant Contact DOREEN EDEY
Correspondent
Sancella, Inc.
6-2300 Bristol Cir.
Oakville, Ontario L6h 5s2
Canada,  CA
Correspondent Contact DOREEN EDEY
Regulation Number880.6060
Classification Product Code
KME  
Date Received05/01/1991
Decision Date 05/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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