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510(k) K860460

MICROTEK STAINLESS STEEL PISTON by Microtek Medical, Inc. — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1986
Date Received
February 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
Review Panel
EN
Submission Type

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  • K061853 — GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT (August 18, 2006)
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