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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K853095
Device Name BOEHRINGER LABORATORIES SUCTION INTERMITTOR
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 Number880.6740
Classification Product Code
GCX  
Date Received07/23/1985
Decision Date 08/23/1985
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
Recalls CDRH Recalls
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