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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 K853880
Device Name ATTENDS DISPOS. UNDERPAD
Applicant
Procter & Gamble Mfg. Co.
P.O. Box 599
Cincinnati,  OH  45201
Applicant Contact JAMES T O'REILLY
Correspondent
Procter & Gamble Mfg. Co.
P.O. Box 599
Cincinnati,  OH  45201
Correspondent Contact JAMES T O'REILLY
Regulation Number880.6060
Classification Product Code
KME  
Date Received09/18/1985
Decision Date 10/16/1985
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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