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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K984157
Device Name MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winstrom-Salem,  NC  27105
Applicant Contact PAULA JOYCE
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winstrom-Salem,  NC  27105
Correspondent Contact PAULA JOYCE
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received11/19/1998
Decision Date 12/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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