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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K894336
Device Name SURGICAL DYNAMICS DISCOGRAPHY SYSTEM
Applicant
Surgical Dynamics, Inc.
650 Whitney St.
San Leandro,  CA  94577
Applicant Contact ALLEN, PHD
Correspondent
Surgical Dynamics, Inc.
650 Whitney St.
San Leandro,  CA  94577
Correspondent Contact ALLEN, PHD
Date Received07/14/1989
Decision Date 08/04/1989
Decision Substantially Equivalent - Kit With Drugs (SEKD)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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