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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 K862684
Device Name AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900
Applicant
Boehringer Laboratories
P.O. Box 870
Norristown,  PA  19404
Applicant Contact JOHN R BOEHRINGER
Correspondent
Boehringer Laboratories
P.O. Box 870
Norristown,  PA  19404
Correspondent Contact JOHN R BOEHRINGER
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/15/1986
Decision Date 10/17/1986
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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