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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophagoscope (Flexible Or Rigid)
510(k) Number K911588
Device Name BRANDT ESOPHAGEAL CYTOLOGY BALLOON
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd. &
5951 Grassy Creek Blvd.
Winston-Salem,  NC  27105
Applicant Contact RICHARD F MARSHALL
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd. &
5951 Grassy Creek Blvd.
Winston-Salem,  NC  27105
Correspondent Contact RICHARD F MARSHALL
Regulation Number874.4710
Classification Product Code
EOX  
Date Received04/09/1991
Decision Date 11/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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