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510(k) K926512

STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE by Storz — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1993
Date Received
December 30, 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

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  • K954340 — STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE (December 14, 1995)
  • K930278 — STORZ COMPUSCAN AB (February 9, 1994)
  • K913504 — STORZ MICRO CUTTER 25 GAUGE PACK (February 21, 1992)

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