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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection, Vacuum
510(k) Number K861025
Device Name T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
Applicant
Boehringer Laboratories
P.O. Box 870
Norristown,  PA  19404
Applicant Contact JOHN BOEHRINGER
Correspondent
Boehringer Laboratories
P.O. Box 870
Norristown,  PA  19404
Correspondent Contact JOHN BOEHRINGER
Regulation Number880.6740
Classification Product Code
KDQ  
Date Received03/18/1986
Decision Date 04/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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