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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Manual Surgical Instrument
510(k) Number K921643
Device Name AMSEN POSTERIOR DISC EVACUATOR
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 Number888.4540
Classification Product Code
LXH  
Date Received04/06/1992
Decision Date 06/03/1992
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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