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510(k) K014274

NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 by Nidek, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2002
Date Received
December 27, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

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  • K990119 — EPI-STAR SURGICAL LASER SYSTER (July 27, 2000)
  • K990900 — MICROKERATOME, MODEL MK-2000 (September 24, 1999)

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