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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 K850044
Device Name TREADMILL E-17
Applicant
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606
Applicant Contact DAVE JOHNSON
Correspondent
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606
Correspondent Contact DAVE JOHNSON
Regulation Number890.5380
Classification Product Code
IOL  
Date Received01/07/1985
Decision Date 04/04/1985
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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