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510(k) K954340

STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE by Storz — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1995
Date Received
September 18, 1995
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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  • K930278 — STORZ COMPUSCAN AB (February 9, 1994)
  • K926512 — STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE (September 9, 1993)
  • K913504 — STORZ MICRO CUTTER 25 GAUGE PACK (February 21, 1992)

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