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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K884804
Device Name THE COACH
Applicant
Promark, Inc.
9838 Northeast 16th
Bellevue,  WA  98004
Applicant Contact DENNIS K PAYNE
Correspondent
Promark, Inc.
9838 Northeast 16th
Bellevue,  WA  98004
Correspondent Contact DENNIS K PAYNE
Regulation Number870.2300
Classification Product Code
DRT  
Date Received11/17/1988
Decision Date 05/19/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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