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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K061224
Device Name LAPDOC I
Applicant
Robodent GmbH
Kurfurstendamm 213
Berlin,  DE 10719
Applicant Contact JUERGEN BIER
Correspondent
Robodent GmbH
Kurfurstendamm 213
Berlin,  DE 10719
Correspondent Contact JUERGEN BIER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/01/2006
Decision Date 09/05/2006
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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