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510(k) K973584

MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM by Medtech Instruments — Product Code ESW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1998
Date Received
September 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Esophageal
Device Class
Class II
Regulation Number
878.3610
Review Panel
GU
Submission Type

Other clearances by Medtech Instruments

  • K894772 — THERMALGRAPHIC ANALYSER (October 3, 1989)

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