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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 K954193
Device Name SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET
Applicant
Surgical Dynamics, Inc.
2575 Stanwell Dr.
Concord,  CA  94520
Applicant Contact CHARMAINE HENDERSON
Correspondent
Surgical Dynamics, Inc.
2575 Stanwell Dr.
Concord,  CA  94520
Correspondent Contact CHARMAINE HENDERSON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/06/1995
Decision Date 10/23/1995
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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