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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Intranasal Septal
510(k) Number K925173
Device Name BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT
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 Number874.4780
Classification Product Code
LYA  
Date Received10/14/1992
Decision Date 01/15/1993
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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