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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 K022169
Device Name CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES
Applicant
Parallax Medical, Inc.
940 Disc Dr.
Scotts Valley,  CA  95066 -4544
Applicant Contact RICHARD M RUEDY
Correspondent
Parallax Medical, Inc.
940 Disc Dr.
Scotts Valley,  CA  95066 -4544
Correspondent Contact RICHARD M RUEDY
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/03/2002
Decision Date 07/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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