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510(k) K160236

Dual Pump Pack by Abbott Medical Optics, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2016
Date Received
February 1, 2016
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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  • K111446 — SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM (December 21, 2011)
  • K111882 — LAMINAR FLOW PHACO TIPS (November 7, 2011)
  • K111697 — AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM (September 27, 2011)

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