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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 K781227
Device Name TOWELS, SHEETS, PILLOWCASES
Applicant
Abco Dealers, Inc.
MD 
Correspondent
Abco Dealers, Inc.
MD 
Regulation Number880.6060
Classification Product Code
KME  
Date Received07/18/1978
Decision Date 10/17/1978
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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