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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K911568
Device Name GOWN, OPERATING SURGICAL
Applicant
Huntsville Rehabilitation Foundation
2939 Johnson Rd., SW
Huntsville,  AL  35805
Applicant Contact BRYAN DODSON
Correspondent
Huntsville Rehabilitation Foundation
2939 Johnson Rd., SW
Huntsville,  AL  35805
Correspondent Contact BRYAN DODSON
Regulation Number878.4040
Classification Product Code
FYA  
Date Received04/09/1991
Decision Date 04/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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