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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 K843038
Device Name DISPOSABLE PATIENT BLANKET
Applicant
Anago, Inc.
7337 Dogwood Park
Fort Worth,  TX  76118
Applicant Contact SANDY KELLER
Correspondent
Anago, Inc.
7337 Dogwood Park
Fort Worth,  TX  76118
Correspondent Contact SANDY KELLER
Regulation Number880.6060
Classification Product Code
KME  
Date Received08/02/1984
Decision Date 10/24/1984
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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