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510(k) K953959

PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES by Microsurgical Technology, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1995
Date Received
August 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

Other clearances by Microsurgical Technology, Inc.

  • K946194 — WEE BAG O'MERCURY (February 27, 1995)
  • K943672 — PHACO NEEDLES AND TIPS (October 13, 1994)
  • K942403 — INFUSION CANNULA (August 17, 1994)
  • K934844 — INTER TIP T (April 19, 1994)
  • K854402 — THE NEW MCINTYRE I.A. HANDPIECE (December 30, 1985)
  • K854401 — THE NEW MOBILE TIP MCINTYRE CANNULA (December 30, 1985)
  • K853777 — THE NEW MCINTYRE CANNULA (November 21, 1985)
  • K840442 — STERILIZED DISPOS. CYSTOTOME (March 16, 1984)

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