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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K912969
Device Name TORQUE FITTING
Applicant
Freedom Machine, Inc.
2408 Timberloch Pl. D-4
The Woodlands,  TX  77380
Applicant Contact PHYLLIS L.ELLETT
Correspondent
Freedom Machine, Inc.
2408 Timberloch Pl. D-4
The Woodlands,  TX  77380
Correspondent Contact PHYLLIS L.ELLETT
Regulation Number870.4290
Classification Product Code
DTL  
Date Received07/08/1991
Decision Date 11/05/1991
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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