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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 K871587
Device Name THE TELESCAN C.A.R.E. SYSTEM
Applicant
Telescan Medical Systems
10091 St.Er Rd.
Auburn,  CA  95003
Applicant Contact STANLEY WEGNER
Correspondent
Telescan Medical Systems
10091 St.Er Rd.
Auburn,  CA  95003
Correspondent Contact STANLEY WEGNER
Regulation Number870.2800
Classification Product Code
DSH  
Date Received04/24/1987
Decision Date 08/12/1987
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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