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510(k) K862872

FLEXIBLE VISUALIZATION CATHETER by American Edwards Laboratories — Product Code FEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
July 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Special Lens, For Endoscope
Device Class
Class I
Regulation Number
876.1500
Review Panel
GU
Submission Type

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Other clearances for product code FEI

  • K873795 — M-LENS (THIRTY DEGREE ENDOSCOPE) (January 14, 1988)