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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K093399
Device Name PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520
Applicant
Inrad
4375 Donker Court SE
Kentwood,  MI  49512
Applicant Contact MELISSA LALOMIA
Correspondent
Inrad
4375 Donker Court SE
Kentwood,  MI  49512
Correspondent Contact MELISSA LALOMIA
Regulation Number876.1075
Classification Product Code
KNW  
Date Received11/02/2009
Decision Date 11/19/2009
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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