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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K915130
Device Name MAT MEMBRANE AUTOTRANSFUSION SYSTEM
Applicant
Estracorporeal, Inc.
4555 Peach St.
Salt Lake City,  UT  84117
Applicant Contact UDIPI R.SHETTIGAR
Correspondent
Estracorporeal, Inc.
4555 Peach St.
Salt Lake City,  UT  84117
Correspondent Contact UDIPI R.SHETTIGAR
Regulation Number868.5830
Classification Product Code
CAC  
Date Received11/13/1991
Decision Date 02/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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