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510(k) K894592

LAMANO DIRECTORS by Marlo Surgical Technology — Product Code GCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1989
Date Received
July 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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