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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 K953802
Device Name TYMPANOSTOMY TUBE
Applicant
BLUFF CITY MEDICAL TECHNOLOGIES, INC.
5295 EAST SHELBY DR.
MEMPHIS,  TN  38118
Applicant Contact ANTHONY D PRESCOTT
Correspondent
BLUFF CITY MEDICAL TECHNOLOGIES, INC.
5295 EAST SHELBY DR.
MEMPHIS,  TN  38118
Correspondent Contact ANTHONY D PRESCOTT
Regulation Number874.3880
Classification Product Code
ETD  
Date Received08/07/1995
Decision Date 10/24/1995
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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