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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K811758
Device Name ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR
Applicant
Powers Medical Systmes
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Powers Medical Systmes
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2920
Classification Product Code
DXH  
Date Received06/22/1981
Decision Date 08/03/1981
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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