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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 K954699
Device Name BRAY RONGEUR
Applicant
Johnson & Johnson Professionals, Inc.
Rte. 202 N.
Raritan,  NJ  08869
Applicant Contact SIGI CARON
Correspondent
Johnson & Johnson Professionals, Inc.
Rte. 202 N.
Raritan,  NJ  08869
Correspondent Contact SIGI CARON
Regulation Number882.4840
Classification Product Code
HAE  
Date Received10/12/1995
Decision Date 12/06/1995
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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