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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 K854320
Device Name ACKRAD ORAL SUCTION TUBE
Applicant
ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD,  NJ  07016
Applicant Contact BERNARD ACKERMAN
Correspondent
ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD,  NJ  07016
Correspondent Contact BERNARD ACKERMAN
Regulation Number868.6810
Classification Product Code
BSY  
Date Received10/28/1985
Decision Date 01/10/1986
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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