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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 K882430
Device Name HOOD TRACHEAL STOMA BUTTON
Applicant
HOOD LABORATORIES
575 WASHINGTON ST.
PEMBROKE,  MA  02359
Applicant Contact LEWIS H MARTEN
Correspondent
HOOD LABORATORIES
575 WASHINGTON ST.
PEMBROKE,  MA  02359
Correspondent Contact LEWIS H MARTEN
Regulation Number868.5800
Classification Product Code
BTO  
Date Received06/14/1988
Decision Date 06/28/1988
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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