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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bougie, eustachian
510(k) Number K770959
Device Name BOUGIE, FILIFORM, JACKSON
Applicant
V. MUELLER O.V. BAXTER HEALTHCARE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
V. MUELLER O.V. BAXTER HEALTHCARE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.4175
Classification Product Code
KBI  
Date Received05/27/1977
Decision Date 06/14/1977
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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