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510(k) K102154

TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS by The Lagado Corp. — Product Code HQD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 21, 2011
Date Received: July 30, 2010
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Lens, Contact (Other Material) - Daily
Device Class: Class II
Regulation Number: 886.5916
Review Panel: OP
Submission Type

Other clearances by The Lagado Corp.

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K052507 — TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL C (November 2, 2005)
K033599 — ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCA (September 16, 2004)

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