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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon, Epistaxis
510(k) Number K924944
Device Name INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA
Applicant
Westmed Intl.
3351 E. Hemisphere Loop
Tucson,  AZ  85706
Applicant Contact LYNN HAYSE
Correspondent
Westmed Intl.
3351 E. Hemisphere Loop
Tucson,  AZ  85706
Correspondent Contact LYNN HAYSE
Regulation Number874.4100
Classification Product Code
EMX  
Date Received09/30/1992
Decision Date 07/02/1993
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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