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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tympanostomy
510(k) Number K965115
Device Name ROUND WINDOW CATH
Applicant
NEURO-BIOMETRIX, INC.
3151 S. ALBION ST.
DENVER,  CO  80222
Applicant Contact MICHAEL H ARENBERG
Correspondent
NEURO-BIOMETRIX, INC.
3151 S. ALBION ST.
DENVER,  CO  80222
Correspondent Contact MICHAEL H ARENBERG
Regulation Number874.3880
Classification Product Code
ETD  
Date Received12/20/1996
Decision Date 03/10/1997
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
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