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510(k) K050648

SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK by Advanced Medical Optics, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2005
Date Received
March 14, 2005
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 Advanced Medical Optics, Inc.

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  • K060366 — THE AMO OPHTHALMIC SURGICAL SYSTEM (April 7, 2006)
  • K042562 — LENS PLUS REWETTING DROPS (July 29, 2005)
  • K040839 — COMPLETE BLINK-N-CLEAN LENS DROPS (October 19, 2004)
  • K032030 — BLINK CL LUBRICANT EYE DROPS (September 25, 2003)
  • K030092 — COMPLETE BRAND MULTI-PURPOSE SOLUTION (April 4, 2003)

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