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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Disposable
510(k) Number K851957
Device Name CHIBA NEEDLE
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winston-Salem,  NC  27105
Applicant Contact JON WILSON
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winston-Salem,  NC  27105
Correspondent Contact JON WILSON
Regulation Number878.4800
Classification Product Code
GAA  
Date Received05/03/1985
Decision Date 05/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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