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510(k) K913504

STORZ MICRO CUTTER 25 GAUGE PACK by Storz — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1992
Date Received
August 7, 1991
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

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  • K930278 — STORZ COMPUSCAN AB (February 9, 1994)
  • K926512 — STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE (September 9, 1993)

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