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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K970285
Device Name AESUCLAP SOCON SPINAL SYSTEM
Applicant
Aesculap, Inc.
1000 Gateway Blvd.
South San Francisco,  CA  94080
Applicant Contact VICTORIA MACKINNON
Correspondent
Aesculap, Inc.
1000 Gateway Blvd.
South San Francisco,  CA  94080
Correspondent Contact VICTORIA MACKINNON
Regulation Number888.3070
Classification Product Code
MNH  
Date Received01/24/1997
Decision Date 06/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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