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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 K853511
Device Name THE HOOD LIFE SAVER
Applicant
Hood Laboratories
575 Washington St.
Pembroke,  MA  02359
Applicant Contact BRUCE BARBAR
Correspondent
Hood Laboratories
575 Washington St.
Pembroke,  MA  02359
Correspondent Contact BRUCE BARBAR
Regulation Number868.5800
Classification Product Code
BTO  
Date Received08/21/1985
Decision Date 12/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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