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510(k) K980675

SUMMIT KRUMEICH-BARRAQUER MICROKERATOME by Summit Technology, Inc. — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1998
Date Received
February 20, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

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  • K904470 — SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE (December 24, 1990)

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