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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K905023
Device Name AMSET LOCKING PLATE SYSTEM
Applicant
Advanced Med/Surg, Inc.
25590 Seaboard Ln.
Hayward,  CA  94545
Applicant Contact RONALD C ALLEN
Correspondent
Advanced Med/Surg, Inc.
25590 Seaboard Ln.
Hayward,  CA  94545
Correspondent Contact RONALD C ALLEN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/07/1990
Decision Date 01/31/1992
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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