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510(k) K941603

AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE by Allergan Medical Optics — Product Code KYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1994
Date Received
April 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Guide, Intraocular
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

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  • K925254 — AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 (January 7, 1993)
  • 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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