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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 K942844
Device Name LEVEL 1 BLOOD STREAM RECOVERY SYSTEM
Applicant
Level 1 Technologies, Inc.
160 Weymouth St.
Rockland,  MA  02370
Applicant Contact WESLEY H VERKAART
Correspondent
Level 1 Technologies, Inc.
160 Weymouth St.
Rockland,  MA  02370
Correspondent Contact WESLEY H VERKAART
Regulation Number868.5830
Classification Product Code
CAC  
Date Received06/16/1994
Decision Date 04/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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