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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Exerciser, Measuring
510(k) Number K912140
Device Name STAIRMASTER MODEL 6000 ERGOMETER
Applicant
Tri-Tech, Inc.
C/O Richard Hamer Assoc.Inc.
P.O.Box 16598
Fort Woth,  TX  76162
Applicant Contact RICHARD A.HAMER
Correspondent
Tri-Tech, Inc.
C/O Richard Hamer Assoc.Inc.
P.O.Box 16598
Fort Woth,  TX  76162
Correspondent Contact RICHARD A.HAMER
Regulation Number890.5360
Classification Product Code
ISD  
Date Received05/14/1991
Decision Date 12/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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