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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K873172
Device Name HAMILTON-THORN MOTILITY ANALYZER HTM-2000
Applicant
HAMILTON THORNE RESEARCH
30 A CHERRY HILL DR.
DANVERS,  MA  01923
Correspondent
HAMILTON THORNE RESEARCH
30 A CHERRY HILL DR.
DANVERS,  MA  01923
Regulation Number864.5200
Classification Product Code
GKL  
Date Received08/11/1987
Decision Date 11/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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