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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 K874089
Device Name BREATHE WITH EEZ (NASAL DILATOR)
Applicant
BREATHE WITH EEZ CORP.
300 LIBERTY AVE.
BROOKLYN,  NY  11207
Applicant Contact LEO ASKINAZY
Correspondent
BREATHE WITH EEZ CORP.
300 LIBERTY AVE.
BROOKLYN,  NY  11207
Correspondent Contact LEO ASKINAZY
Regulation Number874.3900
Classification Product Code
LWF  
Date Received10/07/1987
Decision Date 12/23/1987
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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