FDA 510(k), K103561, MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
FDA 510(k), K103561, MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
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510(K) Number: K103561
Device Name: MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Manufacturer: MENICON CO. LTD.
Device Classification Name: Lens, Contact (Other Material) - Daily
Regulation Number: 886.5916
Classification Product Code: HQD
Date Received: 12/06/2010
Decision Date: 02/03/2011
Regulation Medical Specialty: Ophthalmic
Device Name: MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Manufacturer: MENICON CO. LTD.
Device Classification Name: Lens, Contact (Other Material) - Daily
Regulation Number: 886.5916
Classification Product Code: HQD
Date Received: 12/06/2010
Decision Date: 02/03/2011
Regulation Medical Specialty: Ophthalmic
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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