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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Manual Surgical Instrument
510(k) Number K943873
Device Name ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
Applicant
Orthomet, Inc.
6301 Cecilia Cir.
Minneapolis,  MN  55439
Applicant Contact DAVID A CANNISTRACI
Correspondent
Orthomet, Inc.
6301 Cecilia Cir.
Minneapolis,  MN  55439
Correspondent Contact DAVID A CANNISTRACI
Regulation Number888.4540
Classification Product Code
LXH  
Date Received08/09/1994
Decision Date 04/26/1995
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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