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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 K992138
Device Name MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
Applicant
MICROMEDICS, INC.
1285 CORPORATE CENTER DR.,
#150
EAGAN,  MN  55121
Applicant Contact CHARLES GROTE
Correspondent
MICROMEDICS, INC.
1285 CORPORATE CENTER DR.,
#150
EAGAN,  MN  55121
Correspondent Contact CHARLES GROTE
Regulation Number874.3495
Classification Product Code
ETA  
Date Received06/24/1999
Decision Date 08/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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