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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K920580
Device Name TRANSDUCER, PRESSURE, CATHETER TIP
Applicant
Medamicus, Inc.
15301 Hwy. 55 W.
Minneapolis,  MN  55447
Applicant Contact TIMOTHY H TUCKER
Correspondent
Medamicus, Inc.
15301 Hwy. 55 W.
Minneapolis,  MN  55447
Correspondent Contact TIMOTHY H TUCKER
Regulation Number870.2870
Classification Product Code
DXO  
Date Received02/10/1992
Decision Date 01/07/1993
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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