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510(k) K001902

BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD by Gyrus Ent LLC — Product Code ETA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2000
Date Received
June 22, 2000
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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