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510(k) K111697

AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM by Abbott Medical Optics, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2011
Date Received
June 17, 2011
Clearance Type
Abbreviated
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

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  • K133115 — COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGL (February 27, 2014)
  • K121721 — LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) (October 15, 2012)
  • K113151 — IFS LASER SYSTEM (March 8, 2012)
  • K111446 — SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM (December 21, 2011)
  • K111882 — LAMINAR FLOW PHACO TIPS (November 7, 2011)

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