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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 K901372
Device Name LAMINECTOMY RONGEUR
Applicant
Zeppelin GmbH
Gistlstrabe 99
D-82049 Pullach
West Germany,  DE
Applicant Contact VON ZEPPELIN
Correspondent
Zeppelin GmbH
Gistlstrabe 99
D-82049 Pullach
West Germany,  DE
Correspondent Contact VON ZEPPELIN
Regulation Number882.4840
Classification Product Code
HAE  
Date Received03/22/1990
Decision Date 06/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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