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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Traction, Non-Powered
510(k) Number K870212
Device Name ARTHROSCOPIC SHOULDER HOLDER
Applicant
Dyonics, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Applicant Contact JOHN J SOKOLOWSKI
Correspondent
Dyonics, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Correspondent Contact JOHN J SOKOLOWSKI
Regulation Number888.5850
Classification Product Code
HST  
Date Received01/20/1987
Decision Date 02/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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