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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K222490
Device Name HBL Blade Assembly
Applicant
Hand Biomechanics Lab, Inc.
77 Scripps Dr., Suite 104
Sacramento,  CA  95825
Applicant Contact Dustin Dequine
Correspondent
Hand Biomechanics Lab, Inc.
77 Scripps Dr., Suite 104
Sacramento,  CA  95825
Correspondent Contact Dustin Dequine
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/17/2022
Decision Date 11/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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