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510(k) K840442

STERILIZED DISPOS. CYSTOTOME by Microsurgical Technology, Inc. — Product Code HMX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1984
Date Received
February 1, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

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  • K934844 — INTER TIP T (April 19, 1994)
  • K854402 — THE NEW MCINTYRE I.A. HANDPIECE (December 30, 1985)
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Other clearances for product code HMX

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  • K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) (May 20, 1997)
  • K943932 — STERISEAL OPHTHALMIC CANNULA (January 18, 1995)
  • K942403 — INFUSION CANNULA (August 17, 1994)
  • K934844 — INTER TIP T (April 19, 1994)
  • K930113 — KIRWAN IRRIGATION/ASPIRATION HANDPIECE (February 17, 1994)
  • K921488 — ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION (May 7, 1992)
  • K915074 — IRRIGATOR/ASPIRATOR PROBE (February 5, 1992)
  • K904074 — VITREORETINAL INFUSION CANNULA (February 26, 1991)