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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 K905014
Device Name AMSET PLD 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 Number888.1100
Classification Product Code
HRX  
Date Received11/06/1990
Decision Date 04/01/1991
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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