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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Treadmill, Powered
510(k) Number K897179
Device Name ORBITER(TM) TREADMILL
Applicant
Lee-Meredith Industries, Inc.
6304 Alder
Houston,  TX  77081
Applicant Contact CLAYTON LEE
Correspondent
Lee-Meredith Industries, Inc.
6304 Alder
Houston,  TX  77081
Correspondent Contact CLAYTON LEE
Regulation Number890.5380
Classification Product Code
IOL  
Date Received12/28/1989
Decision Date 02/15/1990
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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