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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 K955616
Device Name MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE
Applicant
MISTEN MEDICAL CORP.
7220 STOUT RD.
GERMANTOWN,  TN  38138
Applicant Contact GEORGE W MURRAY
Correspondent
MISTEN MEDICAL CORP.
7220 STOUT RD.
GERMANTOWN,  TN  38138
Correspondent Contact GEORGE W MURRAY
Regulation Number874.3880
Classification Product Code
ETD  
Date Received12/11/1995
Decision Date 01/17/1996
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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