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510(k) K984255

OLYMPUS HX-20 SERIES LIGATING DEVICE by Olympus Corp of America — Product Code MND

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1999
Date Received
November 30, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ligator, Esophageal
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type

Other clearances by Olympus Corp of America

  • K944250 — UREA NITROGEN REAGENT (February 8, 1995)

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