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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name rhinoanemometer (measurement of nasal decongestion)
510(k) Number K921452
Device Name ACOUSTIC RHINOMETER
Applicant
HOOD LABORATORIES
575 WASHINGTON ST.
PEMBROKE,  MA  02359
Applicant Contact LEWIS H MARTIN
Correspondent
HOOD LABORATORIES
575 WASHINGTON ST.
PEMBROKE,  MA  02359
Correspondent Contact LEWIS H MARTIN
Regulation Number868.1800
Classification Product Code
BXQ  
Date Received03/26/1992
Decision Date 07/08/1993
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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