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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 K872234
Device Name TRANSCOR RADIO-STETHOSCOPE MB
Applicant
Transcor, Inc.
630 Oakwood Ave.
Suite 438
West Hartford,  CT  06110
Applicant Contact SALTZMAN M.D.
Correspondent
Transcor, Inc.
630 Oakwood Ave.
Suite 438
West Hartford,  CT  06110
Correspondent Contact SALTZMAN M.D.
Regulation Number870.2800
Classification Product Code
DSH  
Date Received06/10/1987
Decision Date 08/11/1987
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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