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510(k) K873795

M-LENS (THIRTY DEGREE ENDOSCOPE) by Opto Vision, Inc. — Product Code FEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1988
Date Received
September 17, 1987
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

Other clearances by Opto Vision, Inc.

  • K892145 — FIBER OPTIC LIGHT TRANSMISSION CABLE (September 29, 1989)

Other clearances for product code FEI

  • K862872 — FLEXIBLE VISUALIZATION CATHETER (October 24, 1986)