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FDA 510(k), K040209, IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
FDA 510(k), K040209, IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
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510(K) Number: K040209
Device Name: IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
Manufacturer: JOHN JOSSY
Device Classification Name: Laser, Ophthalmic
Regulation Number: HQF
Classification Product Code: KXA
Date Received: 01/30/2004
Decision Date: 09/20/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
Manufacturer: JOHN JOSSY
Device Classification Name: Laser, Ophthalmic
Regulation Number: HQF
Classification Product Code: KXA
Date Received: 01/30/2004
Decision Date: 09/20/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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