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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K945572
Device Name CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352
Applicant
Johnson & Johnson Professionals, Inc.
Rte. 202 N.
Raritan,  NJ  08869
Applicant Contact PATRICIA BANKERT
Correspondent
Johnson & Johnson Professionals, Inc.
Rte. 202 N.
Raritan,  NJ  08869
Correspondent Contact PATRICIA BANKERT
Regulation Number882.1480
Classification Product Code
GWG  
Date Received11/14/1994
Decision Date 02/03/1995
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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