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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Partial Ossicular Replacement
510(k) Number K955613
Device Name MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
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 Number874.3450
Classification Product Code
ETB  
Date Received12/11/1995
Decision Date 12/22/1995
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
Predetermined Change
Control Plan Authorized		 No
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