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510(k) K990601

BOJRAB MICRO-TORP, MODEL 7014-5845 by Gyrus Ent LLC — Product Code ETA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1999
Date Received
February 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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