510(k) K010184

CHESS HAND SURGERY SYSTEM by Canica Design, Inc. — Product Code MDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2001
Date Received
January 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type