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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 K851143
Device Name RHINOMANOMETERS NR3, NR4
Applicant
AND/OR CORP.
2801 YOUNGFIELD, SUITE 110
GOLDEN,  CO  80401
Applicant Contact CHARLIE D ANDERSON
Correspondent
AND/OR CORP.
2801 YOUNGFIELD, SUITE 110
GOLDEN,  CO  80401
Correspondent Contact CHARLIE D ANDERSON
Regulation Number868.1800
Classification Product Code
BXQ  
Date Received03/21/1985
Decision Date 05/23/1985
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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