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510(k) K925254

AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 by Allergan Medical Optics — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1993
Date Received
October 19, 1992
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 Allergan Medical Optics

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  • K930320 — AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR (April 7, 1994)
  • K924235 — AMO ELITE (December 23, 1992)
  • K911998 — MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM (July 26, 1991)
  • K893199 — PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR (June 16, 1989)

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