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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, larynx (stents and keels)
510(k) Number K884810
Device Name SILICONE LARYNGEAL STENT
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 Number874.3620
Classification Product Code
FWN  
Date Received11/17/1988
Decision Date 05/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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