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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Nasal
510(k) Number K954914
Device Name BREATHE RIGHT NASAL STRIP
Applicant
Cns, Inc.
1250 Park Rd.
Chanhassen,  MN  55317
Applicant Contact M.W. (ANDY) ANDERSON
Correspondent
Cns, Inc.
1250 Park Rd.
Chanhassen,  MN  55317
Correspondent Contact M.W. (ANDY) ANDERSON
Regulation Number874.3900
Classification Product Code
LWF  
Date Received10/26/1995
Decision Date 02/27/1996
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
Predetermined Change
Control Plan Authorized		 No
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