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510(k) K992138

MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES by Micromedics, Inc. — Product Code ETA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1999
Date Received
June 24, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Replacement, Ossicular Prosthesis, Total
Device Class
Class II
Regulation Number
874.3495
Review Panel
EN
Submission Type

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