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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 K950376
Device Name PARKER MODEL PM
Applicant
Parker Treadmill Co., Inc.
368 Industry Dr.
Auburn,  AL  36830
Applicant Contact ROBERT PARKER
Correspondent
Parker Treadmill Co., Inc.
368 Industry Dr.
Auburn,  AL  36830
Correspondent Contact ROBERT PARKER
Regulation Number890.5380
Classification Product Code
IOL  
Date Received01/31/1995
Decision Date 09/06/1995
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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