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510(k) K894248

CONVERTER SYSTEM by Mira, Inc. — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1990
Date Received
June 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

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  • K923629 — OPHTHALMIC TRICHIASIS PROBE (October 19, 1992)
  • K891601 — POWER OPERATED AND CONTROLLED VITREOUS SCISSORS (May 23, 1989)
  • K890448 — LIGHT SOURCE, ENDOSCOP, XENON ARC (May 8, 1989)
  • K863246 — MIRALITE (October 31, 1986)
  • K863591 — ENDOPHOTOCOAGULATION PROBE (October 10, 1986)
  • K855105 — SIMMONS SHELL (March 31, 1986)

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