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510(k) K031733

NON-CONTACT TONOMETER, MODEL NT-4000 by Nidek, Inc. — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2003
Date Received
June 4, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
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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