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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 K942025
Device Name BURGET NASAL STENT
Applicant
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Applicant Contact H. M KAUFMAN
Correspondent
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Correspondent Contact H. M KAUFMAN
Regulation Number874.3900
Classification Product Code
LWF  
Date Received04/26/1994
Decision Date 10/27/1995
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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