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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 K844230
Device Name RHINOMANOMETER A440 DIGITAL
Applicant
CENTER LABORATORIES, INC.
35 CHANNEL DR.
PORT WASHINGTON,  NY  11050
Applicant Contact JERRY D OLIVER
Correspondent
CENTER LABORATORIES, INC.
35 CHANNEL DR.
PORT WASHINGTON,  NY  11050
Correspondent Contact JERRY D OLIVER
Regulation Number868.1800
Classification Product Code
BXQ  
Date Received11/01/1984
Decision Date 11/27/1984
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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