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510(k) K000457

VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES by Retinalabs.Com — Product Code HMX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2000
Date Received
February 11, 2000
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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Other clearances for product code HMX

  • K010305 — WEISS RETINAL CANNULA (May 2, 2001)
  • 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)
  • K901618 — OCULAR INFUSION CANNULA SYSTEM (May 31, 1990)