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510(k) K855215

AIR/FLUID EXCHANGE SYSTEM by Mira, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1986
Date Received
December 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K941495 — RETURN PATH DIATHERMY HANDLE (July 15, 1994)
  • K933527 — MODIFICATION OF ANTERIOR SEGMENT ELECTRODES (January 25, 1994)
  • K923629 — OPHTHALMIC TRICHIASIS PROBE (October 19, 1992)
  • K894248 — CONVERTER SYSTEM (February 27, 1990)
  • 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)

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