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510(k) K946054

DIPLOMAX by Optical Micro Systems, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1995
Date Received
December 12, 1994
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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  • K844715 — VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY (January 22, 1985)

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