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510(k) K972383

EASY-JET DEVICE by A.Stein - Regulatory Affairs Consulting — Product Code KLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1999
Date Received
June 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Shunt, Endolymphatic With Valve
Device Class
Class II
Regulation Number
874.3850
Review Panel
EN
Submission Type

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  • K973590 — HEMORRELIEF DEVICE (February 5, 1998)
  • K973148 — MACOM (November 20, 1997)