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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 K945105
Device Name POLY/PLATINUM WIRE PISTON
Applicant
Micromed Development Corp.
4911 Creekside Dr.
Clearwater,  FL  34620
Applicant Contact DAN H TREACE
Correspondent
Micromed Development Corp.
4911 Creekside Dr.
Clearwater,  FL  34620
Correspondent Contact DAN H TREACE
Regulation Number874.3450
Classification Product Code
ETB  
Date Received10/18/1994
Decision Date 05/14/1996
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
Predetermined Change
Control Plan Authorized		 No
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