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510(k) K014000

VISTITOME 20-10 MICROKERATOME by Biovision AG — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2002
Date Received
December 4, 2001
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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  • K901636 — DIAMOND ND:YAG OPHTHALMIC LASER (June 22, 1990)

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  • K043150 — AMADEUS II EPIKERATOME (January 31, 2005)
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