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510(k) K944995

IOLAB/SITE PERISTALTIC MODULE by Chiron Vision Corp. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1995
Date Received
October 12, 1994
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 Chiron Vision Corp.

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  • K944993 — IOLAB.SITE CD PHACOEMULSIFICATION MODULE (October 12, 1995)
  • K951292 — PASSPORT FOLDABLE LENS PLACEMENT SYSTEM (June 2, 1995)
  • K944994 — IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE (March 14, 1995)
  • K941550 — AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT (November 22, 1994)
  • K935233 — IOLAB LACRIMAL DUCT CATHETER (September 15, 1994)
  • K925606 — OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS (August 29, 1994)
  • K926412 — MICRON-SCOPE II (July 19, 1994)

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