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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, suction, tracheobronchial
510(k) Number K852079
Device Name PENNINE DERBY YANKAUER
Applicant
PENNINE MEDICAL LTD.
P.O. BOX 648
STOUGHTON,  MA  02072
Applicant Contact DAVID S LOCKE
Correspondent
PENNINE MEDICAL LTD.
P.O. BOX 648
STOUGHTON,  MA  02072
Correspondent Contact DAVID S LOCKE
Regulation Number868.6810
Classification Product Code
BSY  
Date Received05/13/1985
Decision Date 06/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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