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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rongeur, Manual
510(k) Number K062711
Device Name ULTRA LOW PROFILE RONGEUR
Applicant
Baxano, Inc.
5582 Chalon Rd.
Yorba Linda,  CA  92886
Applicant Contact SHARON ROCKWELL
Correspondent
Baxano, Inc.
5582 Chalon Rd.
Yorba Linda,  CA  92886
Correspondent Contact SHARON ROCKWELL
Regulation Number882.4840
Classification Product Code
HAE  
Date Received09/11/2006
Decision Date 03/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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