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510(k) K970727

MPORT FOLDABLE LENS PLACEMENT SYSTEM by Chiron Vision Corp. — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1997
Date Received
February 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Folders And Injectors, Intraocular Lens (Iol)
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

Other clearances by Chiron Vision Corp.

  • K972808 — HANSATOME MICROKERATOME (October 24, 1997)
  • K960414 — SYNERGIST POWER PACK (April 24, 1996)
  • K944993 — IOLAB.SITE CD PHACOEMULSIFICATION MODULE (October 12, 1995)
  • K944995 — IOLAB/SITE PERISTALTIC MODULE (October 5, 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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