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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 K022311
Device Name RHINOSTREAM RHINOMANOMETER MODULE
Applicant
Rhino Metrics A/S
9675 W. 95th St.
Minneapolis,  MN  55344
Applicant Contact DAN EGGAN
Correspondent
Rhino Metrics A/S
9675 W. 95th St.
Minneapolis,  MN  55344
Correspondent Contact DAN EGGAN
Regulation Number868.1800
Classification Product Code
BXQ  
Date Received07/17/2002
Decision Date 10/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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