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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K111290
Device Name PIEZO BONE SURGERY
Applicant
Guilin Woodpecker Medical Instrument Co., Ltd.
7325 Joyce Way
Echo,  OR  97826
Applicant Contact CHARLIE MACK
Correspondent
Guilin Woodpecker Medical Instrument Co., Ltd.
7325 Joyce Way
Echo,  OR  97826
Correspondent Contact CHARLIE MACK
Regulation Number872.4120
Classification Product Code
DZI  
Subsequent Product Code
ELC  
Date Received05/06/2011
Decision Date 11/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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