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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Wrist, Carpal Trapezium
510(k) Number K801952
Device Name SPINE ALIGN
Applicant
B.H. Richardson, D.C.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
B.H. Richardson, D.C.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3770
Classification Product Code
KYI  
Date Received08/18/1980
Decision Date 09/16/1980
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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