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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 K920183
Device Name TECH DYNE - HP-2000, SKREEN TEST, RMS-200
Applicant
TECH DYNE GROUP
2024 TEXOMA PKWY.
SUITE 104A
SHERMAN,  TX  75091
Applicant Contact HOWARD A MAHONEY
Correspondent
TECH DYNE GROUP
2024 TEXOMA PKWY.
SUITE 104A
SHERMAN,  TX  75091
Correspondent Contact HOWARD A MAHONEY
Regulation Number888.1240
Classification Product Code
LBB  
Date Received01/15/1992
Decision Date 06/15/1992
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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