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510(k) K970670

REUSABLE VITRECTOMY PROBE by Altex Vision — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1997
Date Received
February 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by Altex Vision

  • K970673 — DISPOSABLE VITRECTOMY PROBE (May 5, 1997)

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