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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 K011206
Device Name PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES
Applicant
Parallax Medical, Inc.
940 Disc Dr.
Scotts Valley,  CA  95066
Applicant Contact RICHARD M RUEDY
Correspondent
Parallax Medical, Inc.
940 Disc Dr.
Scotts Valley,  CA  95066
Correspondent Contact RICHARD M RUEDY
Regulation Number876.1075
Classification Product Code
KNW  
Date Received04/19/2001
Decision Date 07/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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