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510(k) K932600

MODIFIED SITE POWER HANDPIECE II by Chiron Vision Corp. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1994
Date Received
May 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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  • K935233 — IOLAB LACRIMAL DUCT CATHETER (September 15, 1994)
  • K925606 — OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS (August 29, 1994)

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