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510(k) K925631

PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE by Chiron Intraoptics — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1993
Date Received
November 9, 1992
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 Intraoptics

  • K924165 — OPTISOL-GS CORNEAL STORAGE MEDIA (October 6, 1992)
  • K921728 — DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED (June 9, 1992)
  • K921729 — OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED (June 9, 1992)

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