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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K872087
Device Name UMSC HOLTER MONITORING KIT
Applicant
United Medical Supply Co., Inc.
10570 Bradford Rd.
Littleton,  CO  80127
Applicant Contact WILLIAM E MCCLURG
Correspondent
United Medical Supply Co., Inc.
10570 Bradford Rd.
Littleton,  CO  80127
Correspondent Contact WILLIAM E MCCLURG
Regulation Number870.2800
Classification Product Code
DSH  
Date Received06/01/1987
Decision Date 06/19/1987
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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