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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 K891986
Device Name MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE
Applicant
Mark One Healthcare Products
100 E. 9th Ave.
P.O. Box 160
Runnemede,  NJ  08078
Applicant Contact BARRY A MORSE
Correspondent
Mark One Healthcare Products
100 E. 9th Ave.
P.O. Box 160
Runnemede,  NJ  08078
Correspondent Contact BARRY A MORSE
Regulation Number880.6060
Classification Product Code
KME  
Date Received03/28/1989
Decision Date 12/29/1989
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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