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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bit, Drill
510(k) Number K942906
Device Name AGEE-WRISTJACK PRE-DRILL KIT
Applicant
Hand Biomechanics Lab, Inc.
77 Scripps Dr., Suite 104
Sacramento,  CA  95825
Applicant Contact TIM STALLINGS
Correspondent
Hand Biomechanics Lab, Inc.
77 Scripps Dr., Suite 104
Sacramento,  CA  95825
Correspondent Contact TIM STALLINGS
Regulation Number888.4540
Classification Product Code
HTW  
Date Received06/21/1994
Decision Date 12/22/1994
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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