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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dynamometer, Ac-Powered
510(k) Number K964933
Device Name MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
Applicant
MEKANIKA, INC.
12500 S.W. 152ND ST.
MIAMI,  FL  33177 -1411
Applicant Contact DAVID C HOLMES
Correspondent
MEKANIKA, INC.
12500 S.W. 152ND ST.
MIAMI,  FL  33177 -1411
Correspondent Contact DAVID C HOLMES
Regulation Number888.1240
Classification Product Code
LBB  
Date Received12/10/1996
Decision Date 02/03/1997
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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