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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 K883464
Device Name SURGICAL SHIRT
Applicant
Arkansas Lighthouse For the Blind
P.O. Box 192666
Little Rock,  AR  72219
Applicant Contact JAMES O AVANTS
Correspondent
Arkansas Lighthouse For the Blind
P.O. Box 192666
Little Rock,  AR  72219
Correspondent Contact JAMES O AVANTS
Regulation Number878.4040
Classification Product Code
FYA  
Date Received08/15/1988
Decision Date 08/26/1988
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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