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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pump, Cardiopulmonary Bypass
510(k) Number K894721
Device Name TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE
Applicant
The Traumafuse Co.
2340 Riverbend Rd.
Allentown,  PA  18103
Applicant Contact ROBERT L DOUP
Correspondent
The Traumafuse Co.
2340 Riverbend Rd.
Allentown,  PA  18103
Correspondent Contact ROBERT L DOUP
Regulation Number870.4390
Classification Product Code
DWE  
Date Received07/25/1989
Decision Date 10/20/1989
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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