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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 K862406
Device Name NOZEES NOSTRIL DILATOR
Applicant
NOZEES CO.
705 EDGEWOOD BLVD.
OMAHA,  NE  68128
Applicant Contact MACHADO
Correspondent
NOZEES CO.
705 EDGEWOOD BLVD.
OMAHA,  NE  68128
Correspondent Contact MACHADO
Regulation Number874.3900
Classification Product Code
LWF  
Date Received06/25/1986
Decision Date 09/19/1986
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
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