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510(k) K915457

PHACO 20/20 SYSTEM I by Innovative Medical Systems, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1992
Date Received
December 5, 1991
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

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  • K915456 — PHACO 3000 LINEAR (February 12, 1992)
  • K883599 — LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (September 2, 1988)
  • K880745 — LX-100 SLIDE STAINER (April 27, 1988)
  • K853938 — LX 300 TISSUE PROCESSOR (October 10, 1985)

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