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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 K990866
Device Name QUINTON MEDTRACK CR PLUS TREADMILL
Applicant
QUINTON, INC.
3303 MONTE VILLA PKWY.
BOTHELL,  WA  98021 -8906
Applicant Contact MATTHEW J HEDLUND
Correspondent
QUINTON, INC.
3303 MONTE VILLA PKWY.
BOTHELL,  WA  98021 -8906
Correspondent Contact MATTHEW J HEDLUND
Regulation Number890.5360
Classification Product Code
ISD  
Date Received03/16/1999
Decision Date 04/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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