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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 K963326
Device Name BREATHE FIT
Applicant
Cambridge Assoc.
15 Oak St.
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
Cambridge Assoc.
15 Oak St.
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number874.3900
Classification Product Code
LWF  
Date Received08/23/1996
Decision Date 02/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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