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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 K896043
Device Name MATTRESS COVER FOR MEDICAL PURPOSES
Applicant
Keystone Veterinary Supplies, Inc.
409 Commerce Center
Blackwood,  NJ  08012
Applicant Contact ROBERT E DELANO
Correspondent
Keystone Veterinary Supplies, Inc.
409 Commerce Center
Blackwood,  NJ  08012
Correspondent Contact ROBERT E DELANO
Regulation Number880.6060
Classification Product Code
KME  
Date Received10/16/1989
Decision Date 01/10/1990
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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