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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Pneumatic
510(k) Number K013091
Device Name ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
Applicant
VON ZEPPELIN GMBH
GISTLSTRASSE 99
PULLACH,  DE D-82049
Applicant Contact DIETER VON ZEPPELIN
Correspondent
VON ZEPPELIN GMBH
GISTLSTRASSE 99
PULLACH,  DE D-82049
Correspondent Contact DIETER VON ZEPPELIN
Regulation Number882.4370
Classification Product Code
HBB  
Date Received09/17/2001
Decision Date 01/25/2002
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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