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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K946087
Device Name INCLUSICE II(TM) ENDOSCOPE
Applicant
Sofamor Danek USA,Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact RICHARD W TREHARNE
Correspondent
Sofamor Danek USA,Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact RICHARD W TREHARNE
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/13/1994
Decision Date 11/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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