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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 And Tube Cuff
510(k) Number K897059
Device Name HOOD SPEAKING VALVE
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
JOH  
Date Received12/18/1989
Decision Date 03/12/1990
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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