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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 K954517
Device Name TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT
Applicant
TREBAY MEDICAL CORP.
4911 CREEKSIDE DR.
CLEARWATER,  FL  34620
Applicant Contact DAN H TREACE
Correspondent
TREBAY MEDICAL CORP.
4911 CREEKSIDE DR.
CLEARWATER,  FL  34620
Correspondent Contact DAN H TREACE
Regulation Number874.3450
Classification Product Code
ETB  
Date Received09/28/1995
Decision Date 10/27/1995
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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