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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K843721
Device Name DISPOSABLE ISOLATION GOWN
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
Date Received09/24/1984
Decision Date 10/25/1984
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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