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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K083330
Device Name ECHOTIP ULTRA ULTRASOUND NEEDLE
Applicant
Cook Endoscopy
4900 Bethania Station Rd. &
5951 Grassy Creek Blvd.
Winston-Salem,  NC  27105
Applicant Contact SCOTTIE FARIOLE
Correspondent
Cook Endoscopy
4900 Bethania Station Rd. &
5951 Grassy Creek Blvd.
Winston-Salem,  NC  27105
Correspondent Contact SCOTTIE FARIOLE
Regulation Number876.1075
Classification Product Code
FCG  
Date Received11/12/2008
Decision Date 02/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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