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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Regulator, Vacuum
510(k) Number K853155
Device Name BOEHRINGER LAB SUCTION INTERRUPTER
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
KDP  
Date Received07/29/1985
Decision Date 10/16/1985
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
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