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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name goniometer, ac-powered
510(k) Number K852390
Device Name CMT 1000
Applicant
PRESTIGELINE, INC.
FIVE INEZ DR.
P.O. BOX Q
BRENTWOOD,  NY  11717
Applicant Contact DEL GIARNO
Correspondent
PRESTIGELINE, INC.
FIVE INEZ DR.
P.O. BOX Q
BRENTWOOD,  NY  11717
Correspondent Contact DEL GIARNO
Regulation Number888.1500
Classification Product Code
KQX  
Date Received06/05/1985
Decision Date 07/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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