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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K884235
Device Name COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT
Applicant
Burron Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact PEGGY KEIFFER
Correspondent
Burron Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact PEGGY KEIFFER
Regulation Number870.2850
Classification Product Code
DRS  
Date Received10/07/1988
Decision Date 03/06/1990
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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