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510(k) K840837

TBI TRAINER by Manico — Product Code FEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1985
Date Received
February 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Binocular, For Endoscope
Device Class
Class I
Regulation Number
876.1500
Review Panel
GU
Submission Type