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510(k) K971064

BAYERS BIMANUAL I/A HANDPIECES by Visioncare Devices, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1997
Date Received
March 24, 1997
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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  • K940746 — VIT CUTTER MODEL 94 (June 6, 1994)
  • K904909 — I/A VITROPHAGE MODEL YPR 2001 (January 28, 1991)

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