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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 K892062
Device Name PS3500 ARTHROSCOPIC SURGICAL SYSTEM
Applicant
Dyonics, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Applicant Contact J SOKOLOWSKI
Correspondent
Dyonics, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Correspondent Contact J SOKOLOWSKI
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/30/1989
Decision Date 06/23/1989
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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