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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheostomy (w/wo connector)
510(k) Number K853419
Device Name CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
Applicant
HOOD LABORATORIES
575 WASHINGTON ST.
PEMBROKE,  MA  02359
Applicant Contact PAUL VAYO
Correspondent
HOOD LABORATORIES
575 WASHINGTON ST.
PEMBROKE,  MA  02359
Correspondent Contact PAUL VAYO
Regulation Number868.5800
Classification Product Code
BTO  
Date Received08/14/1985
Decision Date 12/06/1985
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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