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510(k) K961805

TOMEY DTL ELECTRODE by Tomey Corporation USA — Product Code HLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1997
Date Received
May 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Corneal
Device Class
Class II
Regulation Number
886.1220
Review Panel
OP
Submission Type

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