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510(k) K120912

INFINITI(R) VISION SYSTEM by Alcon Manufacturing, Ltd. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2012
Date Received
March 26, 2012
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 Alcon Manufacturing, Ltd.

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  • K101285 — CONSTELLATION VISION SYSTEM (November 12, 2010)
  • K093210 — AQUALASE CAPSULE WASH TIP (March 4, 2010)
  • K063155 — MONARCH III IOL DELIVERY SYSTEM (March 27, 2007)

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