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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K010184
Device Name CHESS HAND SURGERY SYSTEM
Applicant
Canica Design, Inc.
36 Mill St.
Almonte, Ontario,  CA KOA 1AO
Applicant Contact GEORGETTE ROY
Correspondent
Canica Design, Inc.
36 Mill St.
Almonte, Ontario,  CA KOA 1AO
Correspondent Contact GEORGETTE ROY
Regulation Number878.4800
Classification Product Code
MDM  
Date Received01/19/2001
Decision Date 06/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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