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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Replacement, Ossicular Prosthesis, Total
510(k) Number K990601
Device Name BOJRAB MICRO-TORP, MODEL 7014-5845
Applicant
Gyrus Ent LLC
2925 Appling Rd.
Bartlett,  TN  38133
Applicant Contact ALICIA FARAGE
Correspondent
Gyrus Ent LLC
2925 Appling Rd.
Bartlett,  TN  38133
Correspondent Contact ALICIA FARAGE
Regulation Number874.3495
Classification Product Code
ETA  
Date Received02/24/1999
Decision Date 03/31/1999
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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