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510(k) K030401

DISPOSABLE M2-PE MICROKERATOME BLADES by Oasis Medical, Inc. — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2003
Date Received
February 6, 2003
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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  • K980437 — SILICONE PUNCTAL PLUG (April 30, 1998)
  • K950798 — POSTERIOR CAPSULE SHIELD (May 22, 1995)
  • K950241 — OPHTHALMIC SPONGES (February 27, 1995)

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  • K052891 — HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (March 23, 2006)
  • K051486 — NORWOOD ABBEY CENTURION SES EPIKERATOME (July 6, 2005)
  • K043183 — EPI-K (March 25, 2005)
  • K043150 — AMADEUS II EPIKERATOME (January 31, 2005)
  • K042083 — MODIFICATION TO VISITOME 20-10 MICROKERATOME (November 16, 2004)