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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Shunt, Endolymphatic
510(k) Number K897049
Device Name GIBSON ENDOLYMPHATIC SHUNT
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 Number874.3820
Classification Product Code
ESZ  
Date Received12/18/1989
Decision Date 03/16/1990
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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